On 4 May 2026, the European Chemicals Agency (ECHA) opened a harmonised classification and labelling (CLH) consultation for the substance variable domain of camelid heavy-chain antibody (VHH protein, C577H905N169O177S4), against fungal lipid cell membranes, obtained by fermentation in Komagataella phaffii and identified as [ASFBIOF01-02]. The consultation, submitted by the Netherlands under the European Union Classification, Labelling and Packaging (CLP) Regulation, invites stakeholders to provide scientific comments and supporting information until 3 July 2026 regarding the proposed hazard classification of the substance. The consultation forms part of the EU harmonised classification process intended to support consistent hazard communication and regulatory risk management for chemical and biological substances across Member States. According to ECHA, the substance currently has no existing harmonised classification entry in Annex VI of the CLP Regulation. Under the proposed future classification submitted by the Netherlands, the substance would be classified as Skin Sensitisation Category 1B (H317). The proposal indicates that the liquid formulation containing 1.76% active substance was determined to be non-sensitising in Local Lymph Node Assay (LLNA) testing. However, for the dry technical grade active substance (TGAS) containing more than 3.4% of the active VHH protein ASFBIOF01-02, skin sensitisation potential could not be excluded. The proposed specific concentration limit states that Skin Sensitisation Category 1B classification would apply at concentrations above 2.0%.
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