EU: Publication of a provisional ATP text focusing on the reproductive toxicant classification

EU: Publication of a provisional ATP text focusing on the reproductive toxicant classification

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Posted By: Selerant EHS

EU: Publication of a provisional ATP text focusing on the reproductive toxicant classificationThe delegated regulation

Last June 22nd 2022, the European Commission published a provisional text of what will become a new ATP, offering a preview what amendments to Reg. 1272/2008 will be issued in the future. This draft has been based on the opinion of the Committee for Risk Assessment (RAC), the group that prepares the opinions of ECHA related to the risks of substances to human health and the environment in the following REACH and CLP processes, and the evaluation of the expert group CARACAL (Competent authorities for REACH and CLP).

The provisional text: what’s new?

The delegated regulation text reports the intention of adding the following notes to section 1.1.3 of Annex VI to the CLP regulation, modifying the classification criteria for specific hazards for those substances that may have these notes in their harmonized classification:

  • Note X: The classification for the hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is common to all substances in the entry. The hazardous properties of any substances in the entry also depend on the properties of the part of the substance which is not common to all substances in the group. The latter must be evaluated to assess whether more severe classification(s) (i.e. a higher category) or a broader scope of the same classification (additional differentiation, target organs and/or hazard statements) might apply for the hazard class(es) in the entry
  • Note 11: The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual boron compounds that are classified as reproductive toxicant in the mixture as placed on the market is ≥ 0.3 %
  • Note 12: The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual substances covered by this entry in the mixture as placed on the market is equal to, or above, the applicable generic concentration limit for the assigned category, or a specific concentration limit given in this entry

Selerant is paying close attention to the evolution of the regulatory situation and will keep you updated on any news in this regard.

For consulting the provisional text of the regulation available in english

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