Jørgen Larsen. The Waterframework Directive how it affects Biocides

Transcription

1 Jørgen Larsen The Waterframework Directive how it affects Biocides

2 This presentation Interaction between the BPR and the WFD Water Framework Directive (2000/60/EC) (WFD) Environmental Quality Standards (EQS) Relationship between the EQS in WFD and the risk assessment in BPR. alpha cypermethrin as the first case. Reflections PAGE 2

3 Interactions between the BPR and WFD Measures taken under the biocides legislation should not prevent the objectives of the WFD. Active substances that are already listed as PHS under the WFD should not normally be approved, considering that PHS are substances that would meet the exclusion criteria under Article 5(1) of the BPR (ie. PBT) Active substances that are already listed as PS under the WFD may; however, be approved, taking into account that the objective of the WFD lays down a strategy against the pollution of water that involves the progressive reduction of discharges, emission and losses of PS, by a certain timeframe. PAGE 3

4 How the WFD should be taken account in the BPR Annex II Identification of any substances falling within the scope of: The ground water Directive The Priority Substance Directive or Annexes VIII and X to Directive 2000/60/EC PAGE 4

5 Product authorisation According to Annex VI of the BPR: the evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1), where under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments), would undermine the achievement of compliance with the standards laid down in: Directive 2000/60/EC, Directive 2006/118/EC, Directive 1998/83/EC, PAGE 5

6 Groundwater The Groundwater Directive 2006/118/EC has been developed in response to the requirements of Article 17 of the WFD An assessment of groundwater is performed for all active substance where an exposure may be expected under the BPR. The development of harmonized guidance for the assessment of groundwater metabolites from biocides in the EU is of very high importance. The guidance should be comparable to those available for plant protection products. PAGE 6

7 General information about thenwfd The purpose of the WFD is to establish a framework for the protection of inland surface water, transitional waters, coastal waters and groundwater which: Aims at enhanced protection and improvement of the aquatic environment, through specific measures e.g. reduction of discharges, emissions and losses of priority substances (PS) and the cessation or phasing-out of discharges, emissions and losses of the priority hazardous substances (PHS) Ensures the progressive reduction of pollution of groundwater and prevent its further pollution. PAGE 7

8 The PS and PHS are listed in Annex X to the WFD The first list of priority substances (a list of 33 substances) was established in 2001 (Decision 2455/2001/EC). The WFD has been complemented by Directive 2008/105/EC (the Environmental Quality Standards Directive, EQSD), which lays down Environmental Quality Standards (EQS) in surface waters (inland and other) for the Priority Substances, which have to be met to achieve good surface water chemical status. This Directive was recently amended by Directive 2013/39/EU, which added to the list of PS and PHS, and revised the EQS for some existing PS. PAGE 8

9 General information about theeqs In the interests of the Community and for a more effective regulation of surface water protection, it is appropriate to set up EQS for pollutants classified as priority substances at Community level and to leave it to M.S. to lay down, where necessary, rules for remaining pollutants at national level. In order to ensure that the aquatic environment and human health are adequately protected, EQS expressed as an annual average value should be established at a level providing protection against long-term exposure, and maximum allowable concentrations should be established to protect against short-term exposure. PAGE 9

10 Biocides (a.s.) which are approved or included in the review programme identified as PS For the original 33 existing PS: Diuron in PT Isoproturon in PT For existing PS with revised EQS: 0 For new PS (introduced by Directive 2013/39/EU): Cybutryne in PT 21 Cypermethrin in PT 18 Terbutryn in PT 7, 9 and 10 PAGE 10

11 Environmental Quality Standards (EQS) under the WFD The EQS Directive establish the maximum acceptable concentration and/or annual average concentration A long-term standard, expressed as an annual average concentration (AA-EQS) and normally based on chronic toxicity data A short-term standard, reffered to as a maximum acceptable concentration EQS (MAC-EQS) which is based on acute toxicity data. PAGE 11

12 EQS, links to chemical risk assessment under BPR It is important to highlight some conceptual differences between EQS derivation and the estimation of PNEC under BPR. For example: Under the BPR there are opportunities to refine a risk assessment in the light of new data, this is often not the case in EQS derivation An underlying requirement of the WFD is to protect the most sensitive waters in Europe. There is therefore sometimes a requirement to protect a higher proportion of water bodies than for PNECs estimations. In EQS derivation, field and mesocosm data have an important role as lines of evidence (through helping reduce uncertainty) but would not be regarded as higher tier data that would replace laboratory-based ecotox data. PAGE 12

13 Links between the Water Framework Directive and the Biocidal Product Regulation How the WFD should be taken into account in the contest of the approval of biocidal active substances. Should the EQS be used instead of the derived PNEC for surface water in the risk assessment if the EQS is lower than the PNEC value? It was agreed to normally use the PNEC value from the evaluation, however a justification for this decision should be included in the AR. PAGE 13

14 Decission on the aproval of an active substance under the BPR Comparing the PEC with the EQS (Maximum Allowable Concentration or the annual Average). The comparison will be kept in the opinion, nevertheless, a sentence highlighting that this comparison may not be appropriate will be included. The fact that one of the EQS is breached by the PEC may not be reason enough to prevent the approval of the active substance. When monitoring data for a substance are available under the WFD, these should be taken into account at product PAGE 14 authorisation stage.

15 First Case. Approval of Alpha-cypermethrin and the interaction with the WFD Cypermethrin is introduced as a priority substance in Directive 2013/39/EU, which amends Directive 2000/60/EC and Directive 2008/105/EC as regards priority substances in the field of water policy. The AA-EQS is 60 times lower than the aquatic Predicted No-Effect Concentration (PNEC) established for alphacypermethrin. also a MAC-EQS for cypermethrin was established for cypermethrin. Again, this standard is lower than the established aquatic PNECaquatic, this time by a factor of 8. PAGE 15

16 Comparing the PEC of cypermethrin (from BPR) with the EQS (from WFD) In the case of alpha-cypermethrin, the aquatic PECs are derived from a daily, local emission and represent a concentration in surface water during an emission period. When comparing the lowest calculated PEC with the AA-EQS, it can be concluded that the PEC exceeds the AA-EQS over 3 times Comparing the PECs to MAC-EQS seems more relevant, as this EQS represents a single concentration that may not be exceeded. Here the lowest PEC is lower than the MAC-EQS. PAGE 16

17 Approval of Alpha-cypermethrin and the interaction with the WFD In conclusion and based on the fact that at the time of adoption of this opinion no monitoring data for this substance are available, the comparison of the PECs with the EQS values listed for alpha-cypermethrin as a priority substance under the WFD alone is not reason enough to prevent the approval of alpha-cypermethrin because approval would undermine the achievement of compliance with the standards laid down in the WFD. PAGE 17

18 Consideration of the WFD when deciding on the approval or non-approval of an active substance under the BPR If an active substance is already listed as PS or PHS under the WFD, this should normally be outlined in the assessment report and the ECHA opinion. If the PEC for the surface water established under the BPR exceeds the EQS that was set under the WFD, some explanation should be provided. However, it should be noted that the EQS under the WFD does not necessarily equate to the PNEC based on different data basis and a discussion should be presented in the assessment report concerning the relevance of the comparison made, i.e. between the PEC and the PNEC or EQS. If the substance has not already been listed as a PS or PHS, but a significant concern regarding a risk to surface water is identified during the evaluation under BPR, the substance could be flagged as a potential candidate for further investigation concerning possible inclusion in the Watch List PAGE 18

19 Interactions between the BPR and WFD Measures taken under the biocides legislation should not hinder the objectives of the WFD. There are close interactions between both frameworks, for instance for: The identification of PS (including PHS) The consideration of measures in the regular rewiew of the PS list The establishment of the EQS PAGE 19

20 Reflections Better cooperation between bodies in charge of the implementation of the BPR and the WFD should be ensured. It should also be investigated if and how data collected under the BPR can be used within the works of the WFD, and vice-versa. PAGE 20

21 Reflections However It is questionable, when the authorisation of a biocidal product undermines the compliance with standards, for example according to the WFD standards. In connection of a product authorisation, the risk from an aggregated environmental exposure shall be taken into account; however, applying the principle of priority to the granting of authorisations could be an unjustified discrimination of a new applicant for an authorisation with regard to holders of authorisations for products containing the same active substance. PAGE 21

22 Thank you! PAGE 22