Monitoring and support on emerging topics

With the aim to move towards a non-toxic environment, European authorities are focusing on emerging concerns (endocrine disruptors, nanoparticles, persistent substances in the environment) and are working to better assess and regulate chemicals with these properties. Science and regulations on these emerging concerns are evolving quickly.

EquiTox is used to maintaining a high level of training, information and expertise on emerging concerns. We can provide technical and regulatory monitoring and help you to anticipate the impact of these advances on your markets and strategies.

1- Endocrine disrupting chemicals (EDCs)
Evaluation of the endocrine disrupting(ED) character of chemicals
EDs are a major and complex issue for both health and the environment. Recent developments in the assessment methods developed by the authorities are forcing manufacturers and users of chemical substances to be increasingly proactive in order to ensure the sustainability of their product portfolios.
Equitox uses its expertise to evaluate the ED character of your chemicals. We collect and analyze, based on the weight of evidence, all the relevant toxicological and ecotoxicological data to identify the adverse effect(s) and to assess whether the toxicological mode of action is an ED-one.
Testing strategy to characterize the potential endocrine disrupting (ED) properties of a substance
The assessment of the ED properties of a substance may require the acquisition of new data in order to strenghten the weight of evidence approach and enable you to come to a decision on the ED character.
EquiTox provides its expertise in toxicology and ecotoxicology to develop an integrated testing strategy, using an approach recognized by authorities for EATS (Estrogen-Androgen-Thyroid-Steroidogenic) modes of action, and identify laboratories capable of conducting these complex studies.
Training courses on endocrine disrupting (ED) concerns.
EquiTox’s experts offer tailor-made training on the properties and mechanisms that govern the action of EDs (health / environment), as well as on the current regulatory framework applicable to their detection, evaluation and management.
2- PBT, vPvB et PMT
PBT/vPvB assessment
The PBT/vPvB criteria may lead to the identification of Substances of Very High Concern (SVHC), potentially eligible for REACh authorisation or Biocide (BPR) exclusion/substitution. PBT/vPvB assessment is then a crucial and critical step for the futur of your substances. We gather all useful data (on the substances, the analogs, the QSARs predictions) to result in a PBT/vPvB diagnosis of your substances, and warn you about critical properties, if necessary.
Regulatory and technical monitoring
The criteria for PBT/vPvB identification do not embrace all substances that may pose an important and long-term risk to the environment and human health. Furthermore, new criteria are being developed (PMT, Persistent, Mobile and Toxic), and more broadly Europe would like very persistant substances to be further explored. We can ensure a technical survey on these emerging subjects by analysing the issues, by identifying the potential impacts on your product portofolio and by advising you on your development strategies.
3- Case studies
Endocrine Disruptors (EDs): An emerging concern for supposedly well-known chemicals
Identification and evaluation of endocrine disrupting properties of chemicals are becoming a growing subject of interest in the EU, for citizens, policy makers, Authorities and Industry.
Legal and Technical frameworks are better known with the recent publication of the Delegated Regulations for the BPR (Reg (EU) No 528/2012) and the PPPR (Reg (EC) No 1107/2009) and the subsequent ECHA/EFSA Guidance Documents. Considering this documentation together with the OECD conceptual framework, EQUITOX offers a full range package for Industry.
First of all, one key point is to temper the debate. To that end, experts from EQUITOX provide training based on the science and its legal interpretation. Most of the chemicals currently catching the attention of regulators are characterised by a well-known conventional (eco)toxicological profile. The available historical data has to be correctly interpreted in order to determine if an ED effect can be suspected. Based on this preliminary evaluation, advice on the strategy is provided based on testing and non-testing methods, keeping the main target in mind: an ED is characterised by an ED mode of action with related adverse effects.
This approach has been applied by EQUITOX for both environmental/human health suspected EDs, in the framework of REACH (SVHC, Art. 57(f)) and the BPR.
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