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SCHEER - Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive" - Bisphenol-A

Final Opinion


SCHEER WG on Water Framework Directive
SCHEER members: Marian Scott (Chair), Marco Vighi (Rapporteur), Thomas Backhaus, Teresa Borges, Peter Hoet, Pim de Voogt, Rodica Mariana Ion
External experts: Andrew Johnson, Jan Linders
On request from: European Commission
Adopted on: 12 October 2022

For the draft dossier on Environmental Quality Standards on Bisphenol-A, the SCHEER offers the following opinion:

A probabilistic approach was possible and this allowed an SSD-based freshwater MAC-QSfw,eco of 129 μg L-1 to be derived with a separate marine SSD able to generate a MAC-QSsw,eco of 31 μg L-1, both using an AF of 10. The SCHEER supports this approach but recommends amending the acute dataset (see answer to question 2. from the Commission).

The SCHEER notes that whilst Bisphenol-A (BPA) has a relatively rich dataset concerning its ED properties, there is still some controversy over its ED potency across taxonomic groups. The SCHEER does not endorse basing the final AA-QSfw, eco on the deterministic data evaluation. Instead, the SCHEER recommends using the best-fitting model as the basis for the probabilistic derivation of the final AA-QSfw, eco, using the amended chronic dataset (see answer to question 1. from the Commission).

The SCHEER supports the proposed QSfw sed of 0.82 mg kg-1 and QSsw sed of 0.16 mg kg-1 to protect benthic organisms.

To protect predators from secondary poisoning from BPA exposure through consumption of freshwater food, the SCHEER support the QSBiota, sec pois, fw in fish of 5.96 mg kg-1ww (rounded to 6.0) and 1.73 mg kg-1ww for bivalves (rounded to 1.7), and the associated predicted QSfw biota for fish of 89 μg L-1 and QSfw biota for bivalves of 12 μg L-1. For marine predator secondary poisoning protection, the SCHEER support the QSBiota, sec pois, sw in fish of 2.98 mg kg-1ww and 0.17 mg kg-1ww for bivalves, and the associated predicted QSsw biota for fish of 44 μg L-1 and QSsw biota for bivalves of 1.2 μg L-1.

To protect human health, the QSbiota hh food of 0.005 μg kg-1 and the QSwater hh food of 0.073 ng L-1 for fish and 0.034 ng L-1 for bivalves are based on a provisional TDI of 0.04 ng BPA kg-1bw d-1 proposed by EFSA (2021) whose final Scientific Opinion is not yet published. An EU drinking water QSdw, hh of 2.5 μg L-1 already exists. Thus, the SCHEER confirms that the QSdw hh has been correctly evaluated but its endorsement by the SCHEER is dependent on the confirmation of the TDI of 0.04 ng BPA kg-1bw d-1 (EFSA, 2021). Thus, the SCHEER identifies the AA-QSwater hh, food of 0.034 ng L-1 as provisional critical value, pending confirmation of the TDI.


Bisphenol-A, Water Framework Directive, environmental quality standards

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Final Opinion on Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive - bisphenol-A, 12 October 2022.


6 JULY 2022
(248.87 KB - PDF)