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EC publishes working documents on EDC fitness check

European Commission (EC) publishes set of staff working documents detailing outcomes of the fitness check on endocrine disrupting chemicals (EDCs); recommends simplifications, moving towards single assessment approach, applying data generated within other legislation to food contact materials, considering mixtures

On October 14, 2020, the European Commission (EC) published a working document and related executive summary on the outcomes of a fitness check carried out on the effectiveness of existing EU legislation in managing exposure to endocrine disrupting chemicals (EDCs). The documents were published alongside the release of the new European chemicals strategy, together with a set of other working documents including one addressing per- and polyfluoroalkyl substances (PFAS) and another on managing exposures to chemical mixtures.  Specifically, the fitness check on EDCs “focused on the coherence of EU legislation in this area, and looked at whether the legislation is effective in delivering on its objective to protect human health and the environment by identifying and minimising exposure to these chemicals” (FPF reported).

The executive summary concludes that “based on the limited number of substances that have been identified as endocrine disruptors or as not being endocrine disruptors, the fitness check could find no evidence of inconsistent identification across the legislation.” However, it also recognizes that the current lack of a unified approach within the EU for identifying EDCs “renders decision-making less transparent and more complex.” It suggests the current criteria under the EU plant protection and biocidal products regulations as a potential starting point for a cross-sectorial definition for EU legislation.

The document further identifies a current lack of required mechanistic tests for determining endocrine activity under existing regulations, including REACH. The EC therefore reports that it is working to update the data requirements. The fitness check further recognizes that product-specific legislation such as those on food contact materials (FCMs) do not currently have guidance in place for managing EDCs, and they do not consider such relevant data generated under other legislation, such as REACH. In the aim to move towards a ‘one substance-one assessment’ process, the EC recommends in the document that options for simplification should be explored, including consistent use of generated data across the different pieces of legislation. It also intends to revise current approaches to manage “the risks resulting from aggregate and combined exposures (mixtures) to different endocrine disruptors.”

Reference

European Commission (October 14, 2020). “Commission Staff Document: Executive Summary of the Fitness Check on Endocrine Disruptors.” (pdf)

European Commission (October 14, 2020). “Commission Staff Document: Fitness Check on Endocrine Disruptors.” (pdf)

Read More

Emma Davies (October 22, 2020). “European Commission: ‘No evidence’ that EDs are identified inconsistently.” Chemical Watch

Chemical Watch (October 22, 2020). “Impurities might determine substance ED classification, EU biocides regulators say.”

Clelia Oziel (October 27, 2020). “Commission to target REACH restrictions, PFASs, EDCs first in new strategy.” Chemical Watch

European Commission (October 29, 2020). “Fitness Check on endocrine disruptors: some room for improvement.”

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