Request to RAC to review the RAC opinion in relation to the harmonised classification of lead
On 30 November 2018, RAC adopted an opinion on the harmonised classification and labelling
of lead. The dossier submitter (Denmark) had proposed a classification for environment, for
both the massive and the powder form, as Aquatic acute 1 and Aquatic chronic 1, with M
factors of 10. The RAC opinion confirmed the dossier submitter's proposal but with an Mfactor of 1 for Aquatic acute 1.
Following the adoption of the opinion, manufacturers of the substance provided new
information on the chronic toxicity of lead in the pond snail Lymnea stagnalis (OECD 243).
The new information may have an impact on the classification of lead as Lymnea stagnalis
was considered as the most sensitive species for chronic toxicity on the basis of the available
data when the RAC opinion was developed. In addition, the RAC opinion contains an appendix
describing an alternative view, ultimately not supported by RAC, for the classification of lead
with a particle diameter ≥ 1 mm (i.e., lead in massive form). During the decision making
process, including the consultation of the Commission expert group (i.e., CARACAL) and
taking into account the arguments provided in the alternative view, some concerns have been
expressed with regard to the final decision of RAC not to have a split classification for the
powder and the massive form of lead.
Consequently, the environmental classification of lead should be reviewed by RAC, in
accordance with recital 5 (see below) of the draft Commission Regulation updating the entry
of lead listed in Annex VI of Regulation (EC) No 1272/2008.
Link to the Request to RAC to review the RAC opinion in relation to the harmonised classification of lead