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Fostering regulatory science to address combined exposures to industrial chemicals and pharmaceuticals: from science to evidence-based policies

This topic calls for applied research studies, demonstrating how new tools and methodological approaches from regulatory science that are workable in a regulatory context and are based on the latest scientific evidence, can be applied to identify, quantify and prevent harmful co-exposures to industrial[[In this context the term ‘industrial chemicals is used to identify chemicals of anthropogenic origin, e.g. including pesticides, biocides, cosmetics etc.]] chemicals and pharmaceuticals.

The applicants can address some or all of the following:

  1. Development of innovative tools and analytical methods to detect and measure complex mixtures in the various environmental compartments[[Chemical exposure data resulting from the projects data shall be shared via Information Platform for Chemical Monitoring IPCHEM (https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html). Procedures and the network of reference laboratories established by HBM4EU (https://www.hbm4eu.eu) should be used.]];
  2. Comparisons of different possible regulatory approaches to manage unintentional chemical mixtures and co-exposures, regarding effectiveness (improved protection of health and the environment), workability, cost-effectiveness and benefits to society and business;
  3. Estimations of the degree to which current and possible future regulatory practices/approaches underestimate (or possibly occasionally overestimate) risks related to chemicals exposure (based on particular case studies, modelling and overall estimations);
  4. Develop and apply modelling, statistical approaches and other relevant methods to identify and study the health impacts on human populations and the environment of exposures to combinations of different chemicals, e.g. through linking results from exposure monitoring with observed health effects;
  5. Scientific case studies to identify safety margins for specific unintentional exposures to combination of chemicals to protect human and ecosystems health, while taking into account chronic exposures over longer time scales;
  6. The possible effects on humans, in particular on vulnerable sub-populations, from combined (chronic) exposure to low levels of pharmaceuticals via the environment, taking account the inherent pharmacological properties and the potential for combined effects from co-exposures with other chemicals;
  7. Combining and analysing EU data sources to generate insights on real-life and potential exposure combinations, typical exposure routes and uses;
  8. Development, improvement and validation of models for predicting (chronic) exposure to combinations of chemicals, which can be applied in a premarket stage (risk assessment, risk management measures, including, e.g. authorisation and restriction of chemicals) and possibly already at the design phase of chemicals and materials as well as retrospectively (e.g. in the setting of environmental quality objectives).

Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment[[Commission Communication on the EU strategic approach to pharmaceuticals in the environment COM(2019) 128 final.]].

Humans, wildlife and domestic animals are exposed to combinations of different chemicals via air, water (including the marine environment), food and feed, consumer products, materials and goods. The scientific understanding of combination effects has progressed in recent years and approaches for risk assessment and management of unintentional mixtures and combined exposures to chemicals are available.

In parallel with the development and implementation of regulatory approaches, there is a need to improve the scientific knowledge base. Current knowledge shows that exposures to combinations of chemicals pose risks to ecosystems and human health that may not be sufficiently managed under existing regulations. There is a need to advance regulatory science to provide policy-makers and risk assessors with validated and practically applicable approaches, methods and tools and to study the effectiveness and efficiency of different policy approaches. The effects of exposure of humans and the environment to combinations of chemicals should also be further explored.

  • Scientific evidence to enable prevention and/or mitigation of co-exposure to pharmaceuticals and industrial1 chemicals in the environment and the technosphere.
  • Support the implementation of existing risk assessment and risk management approaches to reduce the most critical exposures, including the setting of limit values for exposures taking into account co-exposures..
  • Support the assessment of new regulatory approaches such as, e.g. Mixture Assessment Factors
  • Support activities on combined exposures as relevant for the Strategic Approach to Pharmaceuticals in the Environment2 and as to be defined in the forthcoming Chemical Strategy for Sustainability[[https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12264-Chemicals-strategy-for-sustainability-]]

Selected projects under this topic are strongly encouraged to continuously share information and participate to joint activities to optimise synergies to address policy-relevant knowledge gaps.

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 to 6 million would allow the specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.