EUROPEAN COMMISSIONDIRECTORATE-GENERALENVIRONMENTDirectorate D - Water, Chemicals & BiotechnologyENV.D.1 - Water

Brussels, 18 February 2011

REQUEST TO THE SCIENTIFIC COMMITTEE ON HEALTH AND THE ENVIRONMENT

ON "CHEMICALS AND THE WATER FRAMEWORK DIRECTIVE: DRAFT ENVIRONMENTAL QUALITY STANDARDS"

This submission comprises "Annex 9" of the above request dated 8 November 2010. It consists of a cover note and EQS dossiers for anthracene and nickel.

If possible, DG Environment would like the SCHER to provide Opinions on the draft EQS by its 30 March Plenary 2011.

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

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ANNEX 9 – COVER NOTE

This annex contains EQS dossiers for anthracene and nickel.

The SCHER is asked to focus on the two generic questions in the request, reproduced below, and on any additional points identified in this cover note.

1. whether the EQS have been correctly and appropriately derived, in the light of the available information and the TGD-EQS;

2. whether the most critical EQS (in terms of impact on environment/health) has been correctly identified.

ANTHRACENE

The SCHER is asked to consider the two generic questions in the request as well as the following specific point.

As in the case of the fluoranthene EQS dossier, there has been discussion in the Sub-Group on Review regarding the AF that should be used for the QS for marine sediment. The dossier lead has proposed using the same ratio between the AFs for freshwater sediment and marine sediment as occurs in the fluoranthene dossier (as submitted to the SCHER). This means that with an (agreed) AF of 50 for freshwater sediment, the AF for marine sediment becomes 250, cf 10 and 50 for fluoranthene.

The principle of "read-across" between the two dossiers appears to be agreed upon. However, as for fluoranthene, some experts in the Sub-Group (in this case industry and some MS) consider that the AF for marine sediment should be the same as for freshwater sediment, i.e. that the additional factor of 5 is not justified and the AF for marine sediment should be 50. Furthermore, they question whether an AF of 250 should be used at all, since it is not among the AFs recommended in the TGD (see Table 5-1). The lead argues that there are other examples where expert judgement has led to non-standard AFs, and that the additional factor of 5 covers the possibility that among the greater diversity of marine sediment species there are more likely to be species more sensitive than those for which ecotoxicity data are available.

The SCHER is asked to consider whether the proposed AF for marine sediment is appropriate, taking into account the above points and the comparability of the anthracene and fluoranthene dossiers.

EQS dossier

NICKEL3

The SCHER is asked to consider the two generic questions in the request, as well as the following specific points.

The EQS dossier contains EQS for water but not yet for sediment; further data and analysis are required to derive an EQS for sediment in the longer term (this is explained in the dossier).

The dossier was agreed by the Sub-Group on Review in the form provided (dated October 2010). The nickel industry then informed the lead Member State (DK) of the imminent availability of higher-tier data obtained for REACH registration purposes that it considered might be used to reduce the AF to 1. The MS lead has reservations about some of the data, in particular regarding the results for snails in the meso(micro)cosm studies, and considers that the AF should remain as 2. Other Sub-Group experts have divergent opinions.

Industry has provided a summary of its studies (attached), which were conducted for it by the Fraunhofer Institute, and the studies are provided separately. A memo from the Fraunhofer concerning the snail data is also attached, along with three documents from the MS lead (DEPA) commenting on the studies, the memo and the choice of AF.

The specific requests to the SCHER are:

(i) Should the higher-tier data be considered in the EQS derivation process for nickel at this point, before being reviewed for REACH? [Notes: (a) The lead MS considers that there are too many outstanding points of discussion/analysis and difficulties with interpretation of the data, especially from the field studies, for the data to be included in the dossier; (b) The Commission is committed to revising the EQS for nickel in the current review, in particular to take into account bioavailability, since the present EQS was acknowledged to be temporary.]

(ii) Do the three lines of evidence (the laboratory data, bioavailability correction and cross-species extrapolation and the new higher-tier data) collectively reduce the uncertainty around the HC5 as derived in the EQS dossier to a point where it can be used as the EQS? [The lead's view is presented in its attached commentary on the choice of AF.]

(iii) Snail abundance in the meso(micro)cosm studies was analysed by the Fraunhofer Institute according to OECD 53 and guidance from De Jong et al (2008) for summarising and evaluating aquatic micro-and mesocosm studies. A NOEC of 24µg/l was obtained. The dossier lead used an alternative approach and arrived at a NOEC of 6µg/l. The SCHER is asked to provide its opinion on the appropriate statistical analysis and on the interpretation and relevance of the study. [The study is presented in the Fraunhofer report (101123-D-Fraunhofer Nickel Final Draft.zip) and the nickel industry's information paper (summary). These are accompanied by a memo from the principal investigator at the Fraunhofer, and the dossier lead's analysis and commentaries/responses. Please note that the industry information paper has been slightly revised since the version of 31 Jan to which the dossier lead's comments refer.]

EQS dossier

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Industry higher-tier studies - summary and comments (including from the dossier lead)

Industry studies

The attached letter introduces 5 documents containing the studies and the Fraunhofer analytical report. The 5 documents are provided separately because of their size.

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