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    Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards

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    Authors
    Vos JH
    Janssen MPM
    Series/Report no.
    RIVM Rapport 601500001
    Type
    Report
    Language
    en
    
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    Title
    Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards
    Translated Title
    Vergelijking van richtsnoeren ter ondersteuning van Europese risicobeoordelingen met richtlijnen voor de afleiding Europese waterkwaliteitsnormen
    Publiekssamenvatting
    Risico's van nieuwe en bestaande stoffen en van biociden worden in Europa beoordeeld aan de hand van het Technical Guidance Document (TGD) van de Europese Commissie. De Kaderrichtlijn Water verwijst naar de TGD voor het afleiden van waternormen. Daarnaast is in opdracht van de Europese Commissie het Fraunhofer rapport (FHI rapport) afgeleid van de TGD voor de normafleiding voor water. In onderhavig rapport worden de twee richtsnoeren vergeleken om verschillen in normafleiding te bestuderen. Verschillen in kaders, doelstellingen en methodologie worden beschreven, evenals verschillen van meer technische aard. De risicobeoordeling volgens de TGD omvat beoordeling van effecten, beoordeling van blootstelling en risicokarakterisering. De beoordeling van milieu-effecten bleek grotendeels overeen te komen met de normstelling volgens het FHI rapport. De verschillen waren voornamelijk van technische aard. De keuze voor de waternorm volgens het FHI rapport zou voor sommige stoffen echter kunnen leiden tot een lagere waarde dan de veilige waterconcentratie volgens de TGD. Volgens de Fraunhofer methode worden namelijk veilige waterconcentraties afgeleid van veilige doses of concentraties voor predatoren en mensen, terwijl volgens de TGD alleen een veilige waterconcentratie voor waterorganismen wordt berekend. Daarnaast bepaalt de risicobeoordeling volgens de TGD blootstelling via alle relevante routes, terwijl het FHI rapport alleen de waterroute in acht neemt. Het is daardoor theoretisch mogelijk dat de waternorm mens en dier niet voldoende beschermt tegen stoffen die voornamelijk via lucht of voedsel worden ingenomen.

    Risks of both new and existing substances and of biocides in Europe are being evaluated using the Technical Guidance Document (TGD). The European Water Framework Directive refers to this document for establishing Environmental Quality Standards (EQSs) for water. Another guidance document for the derivation of EQSs was developed on the basis of the TGD by the Fraunhofer Institt (FHI) on request of the European Commission. Our study, as documented in this report, aimed to elucidate differences between the two guidance documents. Besides describing the main differences in background, aim and methodology, we also considered discrepancies at a more technical level. Risk assessment described in the TGD encompasses effect assessment, exposure assessment and risk characterisation. Determination of EQSs in the FHI document was found to overlap with the environmental effect assessment of the TGD. Differences were partly technical; however, for certain substances the Fraunhofer method could lead to lower values of EQS for water compared to the derivation of safe water concentrations (PNECs) according to the TGD. Only one PNEC for water is derived following the TGD, whereas according to the FHI document, several EQSs for water are calculated from toxicity data for predators and human consumption of aquatic products. Additionally, risk assessment described in the TGD takes into account multiple exposure routes, while the FHI document only encompasses exposure via water. Therefore, it is theoretically possibly that adopting PNECs as EQSs for the water compartment will not fully protect human health in the case of substantial exposure via air or food.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
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    VROM-BWL
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