Minutes of SG-R (6) meeting. 4 February 2011, Brussels, Belgium

/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D – Water, Chemicals and Biotechnology
ENV.D1 – Water

Sub-Group on Review of WFD Priority Substances List
6th meeting
4February 2011
Draft Minutes (not yet reviewed by COM)

Friday 4February9:00h -18:00h

Room 0C, DG ENV, BU-5, Avenue de Beaulieu 5, 1160 Bruxelles

Chairs: Ana PAYA PEREZ (JRC) and John BATTY (DEFRA, UK)

1.Welcome and adoption of the Agenda

The Chair (John BATTY (JB), DEFRA, UK)welcomed all the attendees and informed that the meeting will be held in the same format as the previous one, with presentations of the updates made on EQS for new and existing substances followed by an open floor for comments and corresponding responses.

2.Introduction

  • Agenda of the meeting

The Chair (JB) asked for adoption for the agenda. The COM (Helen Clayton (HC), DG ENV) specified that cyanides will be discussed on the basis of additional documents uploaded lately on CIRCA.

The agenda is adopted without any amendments.

  • Minutes of previous meeting

Document: DRAFT Minutes SG-R PS 14 Dec 2010.doc

No comments were received so far on the minutes of the previous meeting. They are welcomed until the end of next week, 11 Feb 2011.

  • Objectives of the meeting

The Chair (JB) informed the participants that meeting objectives were the finalisation of some Environmental Quality Standard dossier and to discuss the status of others. He informed the participants this will be an intensive meeting.

3.General update on EQS setting

  • Requests to SCHER re draft EQS

COM HCinformed the meeting that so far, most of the EQS FSwere sent to the SCHER except the one for steroid hormones, NDL-PCBs and cyanides. Steroid hormones are very likely to be sent on the next week and cyanides should wait for further development, but it may be that NDL-PCBs are not sent at all in the future as it is most likely that no EQSis derived.

She added that lead and dioxins have also been sent to SCHER and that 2 documents were presented at last WG E meeting (27-28 Jan 2011) on the state of play of EQS FS of new and existing priority substances.

DocumentsWG E(12)-11-03.2b - Draft EQS and dossier status for proposed PS at 26 January 2011.doc

WG E(12)-11-03.3a - Draft EQS and dossier status for existing PS at 26 January 2011.doc

4.EQS derivation/revision

4.1.Anthracene (INERIS as COM consultant)

The update on the EQS FS was presented by the rapporteur COM Consultant (Alice James, (AJ), INERIS). Indications were given on what had changed in the document since last meeting (e.g.human health section as regards TLhh following comments from NL and AT)and which had been sent to the group mid January, and on comments sent by CONCAWE on some issues which are:

  • that anthracene is not a photo-toxicant as such,
  • that the ecotoxicological data and the common understanding that anthracene itself exerts its ecotoxicological effect through a non-specific mode of action do not warrant an additional safety factor for the marine EQS for sediments
  • that BCF of 19000 used for molluscs to back calculate QSbiota values into water is deemed irrelevant.

CONCAWE (Klaas den Haan, KdH) added that the first issue is rather a problem of semantic, i.e. anthracene is according to him not a phototoxicant as such, but its photo activation couldinduce some adverse effects to aquatic organisms.As this regard, NL (Eric Verbruggen, EV) thought that anthracene is all the more a phototoxicantthat it becomes toxic after UV radiation occurred and he added that this is visible in transparent organisms. CONCAWE (KdH) still claimedthe fact that this was a matter of definition of what is a phototoxicant.NL (EV) agreed that this is a semantic issue but added that the wording “phototoxic” was acknowledged in the literature.

To solve the disagreement and upon CONCAWE’s proposal, it was concluded on this point that reference would be made in the EQS FS to “photo-induced toxicity” rather than “phototoxicity”.

IT (Mario Carere, MC) added that they had sent comments/proposition for QSsed, marine on the day before the meeting including correction of the value with field method. NL (EV) answered that the use of sediment-dwelling data combined to assessment factor method should be applied as a priority compared to the EqP method and clarification was made by the COM consultant (AJ) with IT that such data were available already (e.g. on Lumbriculus variegatus) and that assessment factor method had in fact been applied in the EQS FS. Finally, clarification was also made by NL (EV) that according to EQS TGD, this data should be used for marine QS even if it is a freshwater organism. It was concluded that IT should check by the end of the week if comments wereto be maintained or not.

UK (Paul Whitehouse, PW) askedfor clarification on the other changes made in the FS that were not addressed in the introductory presentation, i.e. that proposed EQS was not driven anymore by a QSbiota but by QSwater, eco following the changes which had been made in the bioaccumulation/biomagnification section (BMF equal to one has considerably increased the value of QSbiota). The point was clarified by the COM consultant (AJ) which agreed with UK statement.

As regards additional AF for QSmarine, sedNL (EV) added that assessment factor might be reduced given the high number of studies. The COM consultant (Sandrine Andrés (SA), INERIS) asked him for clarification on whether the“high number of studies” argument applied to water or to sediment data set. NL (EV) answered that in fact, confusion was made with fluoranthene EQS FS for which there were numerous data for sediment-dwelling organisms.

According to CONCAWE (KdH), anadditional assessment factor was justified nor given the non specific mode of action, neither by the difference in sensitivities of freshwater and marine organisms.DK (Henning Clausen, HC) claimed that according to EQS TGD, the argumentation pleading for an additional assessment factor of 10 when deriving EQS for marine waters was linked to a greater diversity in the marine environment, not to a higher sensitivity of marine organisms.CONCAWE (KdH) answered that the guidance should be usedas a guidance, not as a rule and that this implied possible deviation from the recommended methodology. On this issue, UK (PW) agreed with DK. NL (EV) added that according to them, the non specific mode of action argument did not specifically apply to anthracene. CONCAWE (KdH) added that phototoxicity was not an argument that should apply for sediment data. CH (Marion Junghans, MJ) answered that phototoxicity might be significant for sediment toxicity in low depth aquatic media such as the Wadden sea.

DK (HC)thought that this was typically a borderline case where not 2additional specific marine taxa were represented but only one, e.g. echinoderms. Therefore, in this case the additional assessment factor should apply according to DK.It was added that in environment such as the Great Lakes, light might reach the bottom and toxicity linked to anthracene and degradation product could appear, and this could apply to other PAHs. CONCAWE (KdH) answered that this was assessing mixture toxicity and going too far???. NL (EV) agreed that this discussion addressed another topic which could be reformulated: “should this EQS be studied with other PAHs as a whole, i.e. in an EQS FS addressing PAHs as a group”? This was a very relevant question to ask and NL (EV) acknowledged that they might have pleaded for an integrated approach for PAHs but thought this was now far too late at this step of the process.

As regard this disagreementbetween parties on the assessment factor for QS marine sediment derivation, it was proposed by the COM consultant (SA) that the assessment factor might be reduced based on bridging from fluoranthene EQS FS for which more information on benthic organisms is available. The COM (HC) asked if this proposal was applicable despite the fact that EQS proposal was not driven by the same QS for the two substances. NL (EV) answered that this was in fact acceptable because the two substances had a similar mode of action and that bridging was done only within a single compartment.

As regards the third comment made by CONCAWE that the BCF used for molluscs to back calculate QSbiota into water was irrelevant, the COM consultant (AJm)informedthat BCF values drove the QSbiotavalues as expressed into water but that these QS values were not driving the overall QS in anyway. NL (EV) added that in such cases the food baskets could be looked at but it did not seem necessary since the BCF did not have a direct impact on the EQS proposal.CONCAWE (KdH)answeredthat even if BCF value was not the driving factor, the value reported had to be valid as are other values in EQS FS for other substances.NL (EV) claimed that this study was validated by RIVM as a valid study for BCF use purposes but CONCAWE (KdH) added that according to the definition of a BCF, the only substance in the paper for which the BCF was usable as such was for substances like aldrin. For others, it was clearly demonstrated in the publications that organisms were exposed to only a few percentage (4.6% for anthracene) of the substances as in the dissolved phase.DK (HC) askedfor clarification whether the BCF would under- or over-estimate the EQS FS by this bias but CONCAWE (KdH) added that this was still not a BCF value as organisms were exposed to particulate matter rather than dissolved material. ECPA (Mick Hamer, MH) added that there seem to be a lot of uncertainties regarding this BCF study.

A discussion was then lead between DK, NL and CONCAWE as regards the status of this value being rather a BAF (according to DK and NL) rather than a BCF but NL (EV) specified that it was always the case for molluscs experimental BCF that mussels were exposed to water fed algae and therefore, values calculated based on such studies could only be BAF, not real BCF values. NL (EV) concluded b ysaying that even if this value was a BAF, it was still a data representative of what happened in the field and so it seemed relevant to use it.

The COM consultant (SA) asked if it would be acceptable to everyone if the value was kept for calculations but with all the information available clearly mentioned in the EQS FS, i.e. (i) that the value was rather a BAF (and not BCF), (ii) that this value was used for calculation only as a very worst case value and that (iii) as long as this value was not the driving factor for the overall QS, it did not have an incidence on the overall result. CONCAWE answered that if this was made very clear in the EQS FS, he could agree with this proposal.

Conclusions:

-Rapporteur (COM consultant, INERIS) to provide a new version of the EQS FS by 9 Feb

-Any comments on this version to be sent by Friday 11 Feb

4.2.PAHs (COM/Consultant)

The update on the EQS FS was made by the rapporteur (COM Consultant, INERIS, AJ). Indications were given on what had changed in the document since last meeting (e.g. MAC proposals, QSbiota, hh driving the EQS for the 4 carcinogenic compounds based on data from Benzo[a]pyrene (BaP), EQS for benzo[g,h,i]perylene, back calculation to water and corresponding BCF and BMF values used for this) which was sent to the group mid January. She added that no comments had been received on this EQS FS up to date.

4.2.1.4 carcinogenic substances

IT (MC) informed the meeting that IThad proposed also an EQS for sediment for BaP(BaP) for transitional and marine waters (comments sent the day before the meeting). Clarification was asked by NL (EV) and the COM consultant (AJm) as whether IT proposedto express the proposed EQS (driven by QSbiota, hh) in sediment or to propose an EQS based on QSsediment. IT (MC) proposed to use QSwater, ecoto derive the overall QS, adding an AF to take account of secondary poisoning.

SE (Nikklas Johansson, NK) noticed that as regards theexpression of QSwaterecoas dissolved versus total material, the EQS TGD was not in line with the former EQS methodology (Lepper, 2005[1]) for which it was always total water. Also, he added that this was not in line with the CMEP biota and monitoring guidance. As this regards, the COM consultant (SA) specified that the choice of the recommended matrix remains to be made, and a harmonised approach should be defined. NL (EV) added that EQS TGD was almost finalised so this couldnot possibly be discussed again. He claimed that all (eco)toxicity and BMF datawere all based on dissolved concentrations.Hence, it would be scientifically wrong to state that the EQS derived were to be applied to total concentrations.Finally, it was added by the COM consultant (SA) that this is the way it was dealt within EUSES and in the former TGD.NL (EV)hypothesised that a way out would be to monitor first and then use the results of solid phase extractionto compare to EQS.

SE (NJ) questioned the relevancy of the global approachadopted in the current EQS factsheet applying the Reg. 1991/2006 BaP maximum value in foodstuff to the sum of the 4 carcinogenic substances.According to him, this approach would lead to underestimation of the risk when it was demonstrated that BaP represents only 1/20 of PAHs in the media. The COM consultant (AJm) specified that the EQS FS was dealt with in accordance with conclusions of last SG-R meeting. The COM consultant (SA) added that the approach was rather over-conservative than under-conservative. SE (NJ) agreed that the higher toxicity of BaPwas acknowledged at the time 1991/2006 was published but he added that since then, an EFSA opinion had been undertaken which raised the statement that this might not be so sure anymore. More precisely, BaP would not be a good marker of PAHs exposure. According to NL (EV), BaP as marker compound for exposure of all PAHs substances was the way the Reg. should be readfor fish consumption. NL (EV) added that in RIVM report[2], a cancer risk value was available for BaP of 0.5 µg.kg-1bw.d-1 for a 10-4 life time cancer risk, which led to the calculation of a 0.005 µg.kg-1bw.d-1 for a 10-6 life time cancer risk and a QSbiota, hh of 0.3 µg.kg-1biota. For the 3 other carcinogenic substances, a QSbiota, hh of 3 µg.kg-1biota iswas found.

SE (NJ)indicated that according to the draft EFSA opinion, only one third of exposure came from fish and seafood while the main contribution was from cereals.

IT (MC) was of the opinion that BaP Reg. 1991/2006 value should be applied to BaP, while for other substances QSbiota,hh should be based on available TDI or EFSA opinion results.

NL (EV) did not know how values in EU Reg. had been derived but they probably didnot originate from TDI values, otherwise there should not be differences between fish and molluscs values. Hence, it was definitely more a matter of what value should be used. NL (EV) and UK (PW) agreed to check if the guidance was applicable with the value proposed.

NL (Dorien ten Hulscher, DTH) specified that the approach followed was exactly what was done in the previous EQS derivation round for hexachlorobenzene and what had been proposed in EQS FS for dioxins which would be presented further during the meeting [see below].

NL (EV) came back to the global approach and questioned if the standard should apply for each compound or to the sum of the four and if a kind of TEQ approach would be relevant.UK (PW) added that for the application of a TEQ approach, the proportion of each PAHs’ effectswould need to be defined.NL (EV) informed the meeting that according to the RIVM report above cited, it was noted that the other PAHs (from the ones studied) are a factor of 10 less potent than BaP.UK (PW) followed the reasoning by saying that then it is the occurrence of each compoundthat neededto be defined.NL (EV) evoked the possible use of the toxic unit (TU) approach.

SE (NJ) noticed thatunfortunately, the occurrence pattern would vary too much to be globally/averagely defined. As regards TU approach, there had been already many tries but which never reached an international / European consensus. However, if the main toxicity came from BaP, then, it should be accepted that the BaP TLhh was set for the rest of PAHs in this exercise, considering then that those were as toxic as BaP, although it was known that they were less toxic.

UK (PW) noticed that this approach could lead to false positive results and might be contentious in the future. He proposed a kind of screening for EQS values which should trigger estimation rather than classification.

Since, there seemed to be no clear way forward and UK (PW) and NL (EV) tried to summarisethe different options available:

  • Should the EQS be based on a worst case assumption (based on BaP for all compounds)?
  • Should a TEQ approach be used assuming a constant distribution of PAHs which is not the case in the field?
  • Should EQS be derived from a food standard or from TDIvalues available?
  • Should EQS applyto the sum of the 4 compounds or to one compound representing a marker of effects?

UK (PW) cited the EQS TGD which recommended the use of maximum levels in foodstuffs and proposed to submit a covering note to the SCHER specifying that the approach was “not fully valid as a scientific point of view” but that “none of the alternatives were acceptable either”.