00:00
5:03:59

Ask a Question

Nora

07:17
What was the code to join the event here?

paula chira

07:18
For tomorrow, is the same connection link available?

  • Moderator

    07:17
    There will not be streaming tomorrow so no link unfortunately

Maria MIJA

07:18
Regarding dissociates, is it possible to be create a tool for toxicity determination, according to the production processes? - if it already exists, please inform us.

  • Moderator

    07:32
    Thank you for your question. Which speaker would you like to ask this question?

Eeva Rissanen

07:43
Are you aware of similar road map etc. preparation or guidelines for abandoning animal experiments going on elsewhere in the world

Heike Laue

07:48
Validation of new methods is only the first step. Adoption by OECD as test guideline does not automatically lead to regulatory acceptance. Thus, additional funding would be important to show applicability and reliability of new methods for regulatory applications.

Marianne

07:56
Does the commission plan any initiatives towards universities and the competence buidling of students in these new methods?

Sara Gheim

07:57
What proposals are being considered for Qualification?

Jaana LAITINEN

07:58
The roadmap will be applied to all legislative areas but there are differences in the implementation e.g. current recommendations on Hybit. Could you elaborate on the grounds leading to different approaches on different chemical legislation?

Heike Laue

08:00
Phasing out animal testing: Would be the ultimate long term goal to replace any animal testing including non- protect life stage and invertebrates?

Norna Gabring

08:03
A question regarding the regulatory framework: for CLP the existing animal testing is prioritized in a step wise approach. This means that stakeholders conduct studies on animals in countries outside EU and refer to it as existing data. If this is accepted as existing data then animal testing is indirectly promoted under the clp regulation. Is there any plans to revise clp in terms of the step wise approach to promote the use of validated NAMs?

Nora Stig

08:07
What is the role of AI in phasing out animal-testing? There are no guidance for use of AI in regulatory risk assessment.

Nora Stig

08:15
How does Commission consider development in innovative products that include advanced materials?

Moderator

08:20
Dear participants on site, you can submit your questions from this site www.viestit.io

  • Moderator

    08:20
    And type the code 59 71 95

Johanna BERNERON

09:11
could you please give more details on the use of omics in the OECD 422 TG? Objectives and kind of data that you will be get

Heike Laue

09:14
Would the OMICs sampling not result in a increased use of animals an therefore contradicting the goal to phase out animal testing?

Sara Gheim

09:17
Does ECHA have information on NAMs data submitted by industries and what can be done to improve the currently available NAM methods/data in the immediate term, such as best practices submitted by registrants?

  • ECHA/Elina Brusila

    09:45
    Read-across and grouping is one of the most commonly used alternative approach for data gap filling in REACH registrations submitted. But if we look at specific endpoints, over the last 3 years about 90% of studies are performed in vitro for skin corrosion/irritation and serious eye damage/eye irritation and about 50 % for skin sensitisation. Replacing animal testing “one to one” has been successful for simple endpoints (e.g. skin sensitisation), but under the current regulatory framework, replacing animal testing “one to one” is still challenging for higher tier endpoints like repeat dose and repro toxicity, and registrations still consist mainly of in vivo data.

Georg Streck

09:48
Information on adversity of endocrine disruptors is generated with animal testing. Do you see options to receive information on adversity via NAMs?

  • Sofia Batista Leite

    11:00
    It is something that we are trying to explore. One thing we are doing is collect all ED assessment so far in a database and check the agreement between in vitro and in vivo. But unfortunately we are not there yet, we still don't have a clear strategy on how to confidently assess ED adversity using only NAMs.

Waqar

09:49
In conjunction with the mechanism based RA, do you think it is also important to prioritize an exposure based RA e.g., through TK modeling, as it will be safe to assume that exposure is the primary surrogate of response in an AOP.

SE-Yvonne Andersson

10:59
In which cases/For which kind of substances are the in vitro methods not suitable?

Tomi Kaartinen

11:00
What is your opinion, will classification of substances and mixtures become easier with the NAM data compared to animal data? Or are the difficulties in interpretation of data of equal magnitude but just different?

Norna Gabring

11:14
What are the reasoning for including the DA in the first tier for skin sensitization compared to the other endpoints (eye irritation/skin irritation)? Do you think the tiers will change in the future?

Knud DK EPA

11:16
Example: Skin sensitization (DASS) does for example catch some of most potent compounds: metals

  • Knud DK EPA

    11:24
    does not

Bruno Orthen

11:17
Is there a progress to use non-animal-data with respect to germ cell mutagenicity?

Heike Laue

11:24
Could you please comment on the current status of using OECD 249 for acute fish toxicity for hazard classification?

Knud DK EPA

11:24
Sorry - DOES NOT

Norna Gabring

11:49
How are the 17 assays for DNT intended to be used? Do you think they cover most of the known mechanisms for DNT, and in that case do you think that they can replace animal based methods in the future?

Sussanna Klein

11:54
Could you provide the work done by OECD on developing NAMs for multicomponent nanomaterials?

Knud DK EPA

12:15
How do you see the readiness of models (PBK/IVIVE)

Johanna BERNERON

12:16
The biggest challenge is indeed to maintain the same level of protection for human health and the environment. Are you basing your assessement for genotox on vitro methods only? Or other NAMs?

Waqar

12:23
Does the SCCS have experience of evaluating metabolism profiles using in vitro methods like human primary hepatocyte cell lines?

Jaana LAITINEN

12:35
What has been the impact on the pace of risk assessment and management moving from in-vivo data towards NAMs and WoE based approach?

  • Katie Paul Friedman

    13:36
    Thank you Jaana for the question. I think that so far APCRA has been successful in establishing simple approaches for deriving a NAM-based point of departure. I think APCRA has focused the conversation on what regulatory toxicologists think and need for different contexts (from prioritization to risk-based assessment). I think our papers represent a lot of international viewpoints and so we are gradually moving the conversation to how to use NAMs. While we cannot necessarily affect regulatory contexts based on statutes, we can provide methodology that can be tweaked and adopted. For instance, Health Canada developed a Scientific Approach document based on our 2020 paper that describes an approach they use to prioritize existing chemicals in their Chemical Management Plan.

Tomi Kaartinen

13:43
How would the hazard label look for chemicals classified for systemic toxicity?

Patricia ES

13:49
When is this new GHS hazard class (systemic toxicity) of hazard expected to be ready?

Johanna BERNERON

13:59
do you know when the slides will be available ?

  • Moderator

    14:00
    We hope as soon as possible. We will send them to all registered participants by email.

Opening


10:00 Welcome

Tiina PUTKONEN, Finnish Safety and Chemicals Agency (TUKES)

10:10 Housekeeping and aims of the training

Jukka SUND, Finnish Safety and Chemicals Agency (TUKES)

10:40 Keynote: EU Commission Roadmap towards phasing out animal testing for chemical safety assessment

Georg STRECK, European Commission (DG GROW)


11:20 Coffee break


Overview session


11:50 Towards an animal testing-free regulatory system for industrial chemicals: NAMs at ECHA

Mounir BOUHIFD, European Chemicals Agency (ECHA)

12:20 EFSA activities on NAMs

Sofia BATISTA LEITE, European Food Safety Authority (EFSA)


12:50 Lunch


Regulatory session


13:50 Overview of on-going work at GHS-level on the use of non-animal methods in health hazard classification

Erika WITASP-HENRIKSSON, Swedish Chemicals Agency (KEMI)

14:20 New approach methods in OECD Test Guidelines and beyond

Anne GOURMELON, Organisation for Economic Co-operation and Development (OECD)

14:50 Experiences in performing risk assessment with NAMs

Qasim CHAUDHRY, Scientific Committee on Consumer Safety (SCCS)


15:20 Coffee break


Future opportunities


15:50 Towards a future regulatory framework for chemicals in the European Union – Chemicals 2.0

Elisabet BERGGREN, European Commission (DG Joint Research Centre / EU Reference Laboratory for alternatives to animal testing)

16:20 Performance expectations of new approach methods (NAMs) based on variability and concordance of existing models

Katie PAUL FRIEDMAN, United States Environmental Protection Agency (US EPA)


Closing


17:00 Wrap-up

Jukka SUND, Finnish Safety and Chemicals Agency (TUKES)