Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

PBT asessments are not relevant to metals.

Bioaccumulation: This is not relevant for essential elements: metal-generic information, available from 2009 -2011 EU guidance documents, clearly indicates that a classic BCF approach is not considered relevant. The EU CLP and EU EQS guidance (2009-2011) both indicate that due to homeostatic regulation, the “bioaccumulative” criterion is not applicable to essential metals.

The copper Risk Assessment Report (2008) and REACH Chemical Safety Report (2010) have provided detailed information on (1) the essentiality of copper; (2) the homeostatic control of copper; (3) the mechanisms of action of copper-ions; (4) the comparison between copper toxicity from dietary versus waterborne exposures.

The data clearly demonstrate that:

  • Copper is an essential nutrient for all living organisms
  • Copper ions are homeostatically controlled in all organisms and the control efficiencies increase with trophic chain. As a consequence, - Copper BCF/BAF values decrease with increasing exposure concentrations (water and food), vary depending on nutritional needs (seasonal, life stage, species dependent) and vary pending on “internal detoxification” mechanisms - Copper BMF values are <1.
  • Water-borne exposure (not diet borne exposure) is the exposure route critical to copper toxicity.

The assessment therefore demonstrates that the hazard criterion “bioaccumulative” is not relevant for copper. More details : see attachment.

Persistence: Copper is an element, and as such the criterion “persistence” is not relevant for the metal and its inorganic compounds

Considering the above, copper is neither PBT nor vPvB.