Hi everyone,
I would be very interested in your experiences regarding decives containing substances, that got under official suspicion of having Endocrine Disrupting (ED) properties.
We are currently facing a significant challenge: our product consists almost entirely of a single substance that has now come under ED suspicion. Since a "simple exchange" is not feasible without creating an entirely new product, we are evaluating our strategic options.
How do you handle such cases? Do you immediately move toward justifying the unavoidability of the substance and a lack of alternatives as required per GSPR 10.4.2, or do you focus primarily on refining the toxicological risk assessment and only apply GSPR after the ED property is finally confirmed?
Of course exposure routes and quantities must be re-evaluated, but this raises the question of which Uncertainty Factors (UF) are appropriate to do so. While a factor of 10 x 10 for inter- and intra-individual variation is standard, I am not aware of an officially used UF for EDs. I am considering whether a refined exposure analysis (moving from "worst-case" estimates to actual determined amounts) would be sufficient to achieve a robust Margin of Safety (MoS). Or asked the other way, has anyone had experience with NBs or authorities specifically demanding a extra high MoS for children (due to GSPR highlighting justification of safety of such susceptible individuals) in the context of ED suspicion?
How is your experience with taking additional exposure from other products into account and if, on top of such a calculation, authorities still demand an additional "safety reserve" or buffer here?
In such changes most stakeholders struggle to understand why a product previously considered "safe" is suddenly rated potentially toxic. Since ED suspicions often circulate in expert circles for years before an official publication, many suggest to not take it too seriously until the final classification, assuming it will take years to do so and even might not come. So at that point the discussion is how to handle this situation and finding a suitable way, that fullfills everyones need. Esp. how serious a suspicion needs to be taken and if it triggers the full risk mitigation cycle incl. studies or is there any good reason to postpone it until the final decision?
I would be very grateful for any insights or shared experiences on how to navigate such challenging situation.
Best regards,
I would be very interested in your experiences regarding decives containing substances, that got under official suspicion of having Endocrine Disrupting (ED) properties.
We are currently facing a significant challenge: our product consists almost entirely of a single substance that has now come under ED suspicion. Since a "simple exchange" is not feasible without creating an entirely new product, we are evaluating our strategic options.
How do you handle such cases? Do you immediately move toward justifying the unavoidability of the substance and a lack of alternatives as required per GSPR 10.4.2, or do you focus primarily on refining the toxicological risk assessment and only apply GSPR after the ED property is finally confirmed?
Of course exposure routes and quantities must be re-evaluated, but this raises the question of which Uncertainty Factors (UF) are appropriate to do so. While a factor of 10 x 10 for inter- and intra-individual variation is standard, I am not aware of an officially used UF for EDs. I am considering whether a refined exposure analysis (moving from "worst-case" estimates to actual determined amounts) would be sufficient to achieve a robust Margin of Safety (MoS). Or asked the other way, has anyone had experience with NBs or authorities specifically demanding a extra high MoS for children (due to GSPR highlighting justification of safety of such susceptible individuals) in the context of ED suspicion?
How is your experience with taking additional exposure from other products into account and if, on top of such a calculation, authorities still demand an additional "safety reserve" or buffer here?
In such changes most stakeholders struggle to understand why a product previously considered "safe" is suddenly rated potentially toxic. Since ED suspicions often circulate in expert circles for years before an official publication, many suggest to not take it too seriously until the final classification, assuming it will take years to do so and even might not come. So at that point the discussion is how to handle this situation and finding a suitable way, that fullfills everyones need. Esp. how serious a suspicion needs to be taken and if it triggers the full risk mitigation cycle incl. studies or is there any good reason to postpone it until the final decision?
I would be very grateful for any insights or shared experiences on how to navigate such challenging situation.
Best regards,
