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Public Health
Expert opinion

"Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive" - Clarithromycin

Final Opinion

Description

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
Contact:SANTE-C2-SCHEER@ec.europa.eu
On request from: European Commission
Adopted on: 6 May 2022

For the draft dossier on Environmental Quality standards on clarithromycin, the SCHEER offers the following opinions:

The MAC-QSfw of 0.13 μg L-1 and MAC-QSsw of 0.013 μg L-1 as well as the AA-QSfw of 0.13 μg L-1 and AA-QSsw of 0.013 μg L-1 were acceptable to SCHEER because of the relatively strong supporting literature. Unlike the other macrolide antibiotic dossiers, there is no offer of benthic organism quality standards for clarithromycin.

The SCHEER agreed the clarithromycin chemical characteristics should trigger a secondary
poisoning standard. On 27th April 2022 the JRC reported to the SCHEER that the QSbiota ww of 15.7 μg kg-1 proposed in the dossier was incorrect. The revised calculations would now lead to QSBiota, sec pois, fw 4.7 or 1.6 mg kg-1 ww dependent on whether an AF of 10 or 30 is selected. The SCHEER awaits further confirmation of the final decision on AF.

Regarding human health, a QSbiota, hh of 172 μg kg-1biota ww and an QSdw, hh of 9.8 μg L-1 both derived from an established ADI were endorsed by the SCHEER.

The most critical EQS has been correctly identified as the AA-QSfw of 0.13 μg L-1.

The SCHEER is aware that, for many pharmaceuticals, there are limited environmental data on which to base the derivation of EQS. The key reference used for the deterministic method would have benefitted from more information to allow the reliability of the effect value to be better judged.

Keywords:

Antibiotics, clarithromycin, 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 - Clarithromycin, 6 May 2022.

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