Review of the list of priority substances (Decision 2455/2001/EC) INERIS comments on the

1. Review of the list of priority substances (Decision 2455/2001/EC) INERIS comments on the Draft TECHNICAL GUIDANCE FOR DERIVING EQS

2. Summary • Organisational issues • Terminology / Glossary issues with consequences • Derivation of QSsec pois: • Triggers • Data assessment of toxicological data on vertebrates • Lab to field extrapolation - Conversion of daily dose to food concentrations • Endocrine disruption issue • Derivation of QSsediment : • partition coefficients • default parameters • equilibrium partitioning approach (EqP)

3. Organisational issues • INERIS comments on organisation of the document : • many comments are organisational and/or editorial and/or wording issues • not addressed in this presentation when no other consequence than clarity of the document • see written comments

4. Terminology / glossary issues with consequences • Main comment on terminology referring to the whole document : • EQS vs QS : EQS term used in many occasion when text refers to QS only • Makes the text difficult to understand / interprete • e.g. for determination the relationship between MAC and (E?)QS value (section 3.2.) • INERIS suggestion: • Change EQS term to QS for each occurrence not addressing the overall QS • Relationship with MAC : replace AA-EQS by QSwater eco

5. Terminology / glossary issues with consequences • Main comment on glossary referring to the whole document : • There are many ≠ QSsubscriptthrough the document • INERIS suggestion: • Add all ≠ QSsubscriptin the glossary • Harmonisation and consistencyneededthrough the whole document

6. Derivation of QSbiota sec pois Triggers • Comment referring to section 2.4.1.4. : • Trigger values for QSbiota sec pois : 2 different approaches for organics and metals • organics : no bioaccumulation evidence -> no need for an assessment • for metals (lines 580-583) : “A lack of biomagnification should not be interpreted as lack of exposure or no concern for trophic transfer. Even in the absence of biomagnification, aquatic organisms can bioaccumulate relatively large amounts of metals and this can become a significant source of dietary metal to their predators (U.S. EPA 2007; Reinfelder et al. 1998)”.

7. Derivation of QSbiota sec pois Triggers • INERIS Comment (section 2.4.1.4.) : • same risk happen for very toxic organic compounds for which very low concentrations in food can lead to significant toxicity in mammals. • EQS driven by QSbiota sec pois even for substances with log KOW<3 cases observed in several occurrence for derivation of QS

8. Derivation of QSbiota sec pois Triggers • Incidence on EQS determination : • Significant • some QS can be underestimated

9. Derivation of QSbiota sec pois Data assessment of toxicological data on vertebrates • INERIS comment referring to section 2.4.1.5. : • no clear recommendation for the selection of the data for assessment of secondary poisoning • e.g. are reproduction data preferred to any other systemic effects not likely to have an impact on the population but occurring at lower concentrations ? • INERIS Suggestion : • more detailed recommendation should be given on this issue • an ecotoxicologist judgment is necessary for the definition of the environmental protection goal of secondary poisoning

10. Derivation of QSbiota sec poisLab to field extrapolation – Conversion factor • INERIS comment referring to section 4.4.2 : • Lines 3306 – 3308 : “Table 4-1 presents a guide with a standard set of factors that can be used to promote internal consistency when converting concentrations from dose into diet for mammals. The guide should be used only in the absence of more specific data from the study itself or other sources.” • Lines 3316 – 3318 : “In cases where only the food concentration is available, and information is not available to enable a calculation of the dose, the assessment factors should be increased by a factor of 3 (i.e. as in the TGD)”.

11. Derivation of QSbiota sec poisConversion of daily dose to food concentrations • INERIS comment referring to section 4.4.2 : • Contradictory : dose expressed as food concentration ? • Based on the work done for the time being : in some cases, NOAEL used for secondary poisoning may have been corrected to a systemic dose BUT back calculations from this systemic dose to concentration in food would add uncertainties

12. Derivation of QSbiota sec poisLab to field extrapolation • INERIS comment referring to section 4.4.2 : • Lab to field extrapolation (efficiency absorption) : inconsistency between REACH guidance and TG EQS guidance : • REACH guidance : extrapolation factor taken into account in the step of PNEC derivation (Assessment Factor) • TG EQS guidance : extrapolation factor taken into account in the step of conversion from daily dose to food concentration (Conversion Factor)

13. Derivation of QSbiota sec pois Lab to field extrapolation – Conversion factor • INERIS suggestion: • Recommendations needed: • where to include the lab to field extrapolation factor ? • which value is preferred : dose expressed as food concentration ?

14. Derivation of QSbiota sec poisConversion of daily dose to food concentrations • Incidence on EQS determination : • Significant • e.g. heptachlor, parathion

15. Endocrine disruption issue • INERIS comment referring to section 2.8.2. and 3.4.2.1.1. : • Encouragement in the document for a higher AF when potential for/relevant evidence for endocrine disruption BUT no detailed recommendations on : • the values of these AF • if deemed relevant for wildlife and/or human health ? • if deemed relevant for all ecotoxicological data (aquatic only or also secondary poisoning?) • if deemed relevant for derivation of MAC values ? If not, important precision

16. Endocrine disruption issue • INERIS Suggestion : • tricky issue • need for an expert consultation • for the time being, at least INERIS suggests to add the following sentence : “This factor should be at least of - for recognised ED, of - for suspected ED. No further assessment is needed for secondary poisoning and human health assessment since it is considered that these effects have already been captured by the toxicological assessment.”

17. Endocrine disruption issue • Incidence on EQS determination : • Significant • Affects quite many substances and can lower EQS by a factor of -

18. Derivation of QSsedimentPartition coefficients • INERIS comment referring to section 2.6.1.1. : • “Partition coefficients are needed to conduct transformation calculations (e.g. from mass/volume [mg/L] to mass/mass [mg/kg]). Those coefficients (K) are, for instance: K octanol-water (KOW), K suspended particulate matter – water (Ksusp-water), K sediment-water (Ksed-water), K organic carbon – water (KOC)”. • Ksusp-water and Ksed-water introduced here, but not clear how they have to be used, in particular for derivation of standard for sediment • INERIS Suggestion : • Clarify whether these coefficients should be used and if so, how, especially if needed for derivation of a QSsediment

19. Derivation of QSsedimentPartition coefficients • INERIS comment referring to section 2.6.1.2. : • Use of benthic data for water column determination. • for some specific substances, data from sediment dwelling organisms (e.g. Chironomus) used for determination of QSwater (cases where insects are more sensible than crustaceans, e.g. some insecticides) • INERIS Suggestion : • Add clarification in the text whether: • it is possible to use sediment dwelling organisms data for derivation of QSwater (back calculation from sediment to water) and eventually use them for QSsediment derivation (INERIS position) • OR • back calculation from sediment to water not possible

20. Derivation of QSsedimentDefault parameters • INERIS comment referring to section 5 : • Ecotoxicity testing section: • Line 2926 : (E)QS is to be expressed in dry weight • Line 2927: “a standard sediment has a default OC value of 5%” • Equilibrium partitioning section: • Absence of provision • sediment parameters have to be used rather than SPM ?

21. Derivation of QSsedimentEquilibrium Partitioning method • INERIS comment referring to section 5 : • Direct reference to Di Toro et al. (1991) • Removal of EU TGD equation • Equation given as “Sediment threshold_OC” but no further guidance is provided on how to move : • from this result to “total sediment” • from “wet weight” to “dry weight”

22. Derivation of QSsediment • INERIS Suggestion : • Clarification needed on the purpose of EqP application: • Usual TGD calculations using SPM parameters ? • Usual TGD calculations using SED parameters ? • Other calculations ? • Add a worked example in the guidance even if the EqP approach is not recommended by CSTEE.

23. Derivation of QSsediment • Incidence on EQS determination : • Significant • QSsediment can not be derived for any substance at this step

24. Thank you for your attention