ECHA Releases First Annual Report of Integrated Regulatory Strategy

The European Chemicals Agency (ECHA) has released the first annual report from the Integrated Regulatory Strategy, entitled “Mapping the chemical universe to address substances of concern”. Presenting an overview of the various REACH and CLP processes underway on different chemicals, it discusses efforts to clarify and map the universe of registered substances that are on the European Union (EU) market.

Mapping the Chemicals

The initial focus of this major mapping effort is on the approximately 4,700 chemicals registered above 100 tons. Thus far, more than 2,000 of these chemical substances have been categorized into three main “pools”:

  • High priority for risk management
    • (~ 270 chemicals)
    • Substances of concern for which additional regulatory work is either ongoing or can begin.
  • High priority for data generation
    • (~ 1,300 chemicals)
    • Substances of potential concern for which more data is needed to determine whether additional regulatory risk management is necessary.
  • Low priority for further regulatory action
    • (~ 450 chemicals / ~ 500 chemicals)
    • Approximately 450 chemicals already sufficiently regulated.
    • Approximately 500 chemicals deemed low priority following assessment.

For the roughly 2,700 remaining chemicals, they have been allocated to what is being referred to as an “uncertain area”, as it is unclear to which of the current pools they should be assigned. Additional information and evaluation will be necessary to help determine the outcome of substances in this area.

In a statement from Bjorn Hansen, ECHA Executive Director, he highlighted the significance of the Agency’s efforts, noting “Our work enables authorities to focus on activities that improve human health and the environment in Europe and make the European industry more competitive. We remind industry to further improve the compliance of their registration information, in particular for substances with a high potential for exposure and for which hazard data is currently lacking”.

Key Recommendations

The ECHA notes several principal recommendations in the Integrated Regulatory Strategy report:

  • Optimization of data generation and assessment to ensure timely progression of chemicals to regulatory risk management.
  • Review of appropriateness and priority of chemicals that have previously been identified, but are still pending follow-up actions (with those of high-priority chemicals being progressed to regulatory risk management).
  • Prioritization of harmonized classification and labelling, as it is typically a precursor to restriction, authorization, and other measures.
  • Improved quality of registration information, especially for substances without proper chemical hazard data and those with a high exposure potential.
  • Continued coordination of efforts among various authorities.

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