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Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the WFD"-17-Alpha-Ethinylestradiol (EE2), Beta-Estradiol (E2) and Estrone (E1)

Final Opinion

Cur síos

SCHEER WG on Water Framework Directive
SCHEER members: Marian Scott (Chair), Marco Vighi (Rapporteur), Teresa Borges, Raquel Duarte Davidson, Peter Hoet, Pim de Voogt
External experts: Thomas Backhaus, Andrew Johnson, Jan Linders
Contact:SANTE-C2-SCHEER@ec.europa.eu
On request from: European Commission
Adopted on: 1 March 2022

The dossier on Environmental Quality Standards for “Estrogens” was reviewed by the SCHEER according to the general mandate on EQS dossiers.

The SCHEER endorses that the MAC-QSfw,eco for estrogens was not derived because of the chronic exposure pattern and the large acute to chronic ratios observed.

EE2

The SCHEER is of the opinion that in the deterministic approach an assessment factor (AF) of 50 should be used, instead of 10, which would lead to the AA-QSfw,eco of 0.0032 ng L-1. In the SSD approach, the SCHEER does not agree with lowering the default additional assessment factor to 4. According to the SCHEER, this gives a AA-QSfw,eco of 0.017 ng L-1 . The SCHEER endorses the additional assessment factor of 2 for marine organisms. However, for marine water, data for only one additional typically marine taxonomic group is available (echinoderm species). In that case an extra AF of 5 is applied in addition to the AF of 2, to deal with residual uncertainty. Therefore the SCHEER proposes to set a value of 0.0016 ng L-1 for the AA-QSsw,eco.

The SCHEER cannot endorse the QSsed of 84.10-7 mg Kg-1 ww because of uncertainties in the dossier.

Although the SCHEER endorses the AF of 30 and the BCF of 610 used for the derivation of the QSbiota,secpois, it cannot support the QSbiota,secpois derived because default values for the energy content of feed are not reported.

The SCHEER cannot endorse the QSbiota,hh: the AF of 100 is not supported. It is not clear how the value of 0.0609 ug Kg-1 was derived as reported in Table 7.1. In addition, the QSbiota, hh food should be compared with the QSbiota, secpois. This step was not reported but would result in a standard driven by QSbiota,secpois., being the lower value.

The SCHEER cannot support the calculation of the QSdw,hh since two different values of ADI have been used.

E2

The SCHEER endorses the AA-QSfw,eco in the deterministic approach. In the SSD approach, the SCHEER does not agree with lowering the default assessment factor to 3. Applying the default assessment factor of 5 will give a AA-QSfw,eco of 0.18 ng L-1. The SCHEER endorses the additional assessment factor of 2 for marine organisms. However, no data for typically marine taxonomic groups are available. In that case an extra AF of 10 is applied in addition to the AF of 2, to deal with residual uncertainty. Therefore the SCHEER proposes to set a value of 0.009 ng L-1 for the AA-QSsw,eco .

The SCHEER cannot endorse the QSsed of 13.10-5 mg Kg-1ww because of uncertainties in the dossier.

No QSbiota,secpois was derived because of a missing BMF value. It is not clear why the default value of 1 was not used as was done for EE2. The SCHEER endorses the AF of 30 and the BCF of 6.5 selected for the derivation of the QSbiota,secpois. Default values for the energy content of feed are not reported.

The QSbiota,hh was correctly derived to be 5.2 ug Kg-1 wwt fish. It is not clear how the value of 3.04 ug Kg-1 bw was derived as reported in Table 7.1. In addition, the QSbiota, hh food should be compared with the QSbiota, secpois. This step was not reported but would result in a standard driven by QSbiota,secpois., being the lower value.

According to the SCHEER, it does not seem appropriate to set drinking water limits for E2 and E1, since these hormones have been consumed in milk and dairy products by humans for centuries. The SCHEER agrees with the technical derivation.

Keywords:

estrogens, 17-alpha ethinylestradiol, beta estradiol, and estrone, Water Framework Directive, environmental quality standards

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Preliminary Opinion on "Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive", 17-alpha-ethinylestradiol (EE2), Beta-Estradiol (E2) and Estrone (E1), 1st March 2022.

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