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The Lack of Regulation of Chemical Mixtures and Its Legal Consequences in the Baltic Sea Area

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Regulatory Gaps in Baltic Sea Governance

Part of the book series: MARE Publication Series ((MARE,volume 18))

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Abstract

The chapter discusses the void in legal protection of the Baltic Sea from the combined effects of multiple chemicals. While individual chemicals are subject to detailed regulation at international and EU-level, combinations sometimes fall outside the scope of any rules. The article analyses to what extent EU laws consider potential combination effects of chemicals and how, which types of chemical exposure is considered and how combination effects of chemicals in the Baltic Sea could be regulated in the future.

Our appreciation to colleagues in the research programs NICE (particularly Pontus Nilsson), SPEQS (A systems perspective on environmental quality standards ) and the FRAM Centre for Future Chemical Risk Assessment and Management Strategies.

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Notes

  1. 1.

    UNEP. 2013. Global Chemicals Outlook - Towards Sound Management of Chemicals, 10, available at <http://www.unep.org/hazardoussubstances/Portals/9/Mainstreaming/GCO/The%20Global%20Chemical%20Outlook_Full%20report_15Feb2013.pdf>

  2. 2.

    Backhaus, T., Brooks, B. and Kapustka, L. “Chemical Risk Assessment: Pressures, Perceptions and Expectations” (2010) Integrated Environmental Assessment and Management 6(3), 323.

  3. 3.

    Kortenkamp, A., Backhaus, T., Faust, M. 2009. State of the Art Report on Mixture Toxicity . Report for the Directorate General for the Environment of the EU Commission )

  4. 4.

    UNEP, note 1 at 11.

  5. 5.

    Gray, G. M. and Cohen, J. T. “Rethink chemical risk assessments” (2012) 489(7414) Nature 27–28.

  6. 6.

    Backhaus, T., Faust, M. “Predictive environmental risk assessment of chemical mixtures : a conceptual framework” (2012) 46(5) Environmental Science & Technology 2564–2573.

  7. 7.

    Backhaus, T. An additional assessment factor (MAF) – a suitable approach for improving the regulatory risk assessment of chemical mixtures? (2015) Report for the Swedish Chemicals Agency, Report May (2015).

  8. 8.

    Backhaus, T., Faust, M., Kortenkamp, A. “Cumulative Risk Assessment: a European perspective on the state of the art and the necessary next steps forward.” (2013) 9(4) Integrated Environmental Assessment and Management 547–548. Backhaus, T., Faust, M. Hazard and Risk Assessment of Chemical Mixtures under REACH : State of the Art, Gaps and Options for Improvement (2010) PM for the Swedish Chemicals Agency, PM 3/2010.

  9. 9.

    Fisher, B., Polasky, S., Sterner, T. “Conservation and Human Welfare: Economic Analysis of Ecosystem Services” (2011) 48(2) Environmental and Resource Economics 151–159. See also Backhaus, T., Snape, J., Lazorchak, J. “The impact of chemical pollution on biodiversity and ecosystem services: the need for an improved understanding” (2012) 8(4) Integrated Environmental Assessment and Management 575–576, and Diamond, M., de Wit, C.A., Molander, S., Scheringer, M., Backhaus, T., Arvidsson, R., Bergman, Å., Hauschild, M., Holoubek, I., Lohmann, R., Persson, L., Suzuki, N., Vighi, M., Zetzsch, C. Exploring the planetary boundary for chemical pollution (2015) 78 Environment International 8–15.)

  10. 10.

    Lotze H.K., Lenihan H.S., Bourque B.J., Bradbury R.H., Cooke R.G., Kay M.C., Kidwell S.M., Kirby M.X., Peterson C.H. & Jackson J.B.C. “Depletion, degradation, and recovery potential of estuaries and coastal seas” (2006) 312(5781) Science 1806–1809.

  11. 11.

    HELCOM , 2010. Hazardous substances in the Baltic Sea . An integrated thematic assessment of hazardous substances in the Baltic Sea. Baltic Sea Environment Proceedings No. 120B, north-western Kattegat was the only exception which was classified with a “good” status.

  12. 12.

    Coastal areas that received the highest status classifications were found at wave-exposed sites such as the Åland Archipelago and the coastal waters off Kaliningrad. Assessment units with the poorest status were either located near big cities or ports (Tallinn, Klaipeda) or in estuarine areas (Ruotsinpyhtää in the Gulf of Finland ), Kvädöfjörden in the Western Gotland Basin) or coastal sites (the Kiel Bay area). All common groups of hazardous substances – PCBs, dioxins, heavy metals, organometals, alkylphenols, phthalates, brominated substances, polycyclic aromatic hydrocarbons (PAHs), DDTs and chlorinated pesticides as well as the radionuclide cesium-137 – were found among the substances with the highest concentrations in relation to target levels. See HELCOM, 2010. Hazardous substances in the Baltic Sea An integrated thematic assessment of hazardous substances in the Baltic Sea . Baltic Sea Environment Proceedings No. 120B.

  13. 13.

    Magnusson, K. and Norén, K. The BaltSens project: The sensitivity of the Baltic Sea ecosystems to hazardous compounds (2012) KEMI.

  14. 14.

    Backhaus, T., Faust, M. and Blanck, H. Hazard and Risk Assessment of Chemical Mixtures under REACH . State of the Art, Gaps and Options for Improvement (2010) PM 3/10.

  15. 15.

    SWECO VIAK Kombinationseffekter av. föroreningar (2008) Naturvårdsverket 19.

  16. 16.

    SCHER, SCCS, SCENIHR. Opinion on the Toxicity and Assessment of Chemical Mixtures (2012) 9, and SWECO VIAK, note 15 at 9.

  17. 17.

    SCHER, SCCS, SCENIHR, note 16 at 43. In the US this situation is called cumulative exposure. In Europe, cumulative exposure denotes the release of only one substance from one or several sources through one or several routes . In the US the term for this situation is aggregated exposure. Hazard and risk assessment of chemicals under REACH, 47.

  18. 18.

    HELCOM . Recommendation 19/5 (1998). HELCOM objective with regard to hazardous substances.

  19. 19.

    Council of the European Union Combination effects of chemicals – Council conclusions (2009) 17820/09, available at http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2017820%202009%20INIT

  20. 20.

    Kortenkamp, A., Backhaus, T. and Faust, M. State of the Art Report on Mixture Toxicity (2010) available at http://ec.europa.eu/environment/chemicals/effects/pdf/report_mixture_toxicity.pdf

  21. 21.

    SCHER, SCCS, SCENIHR, note 16.

  22. 22.

    European Commission Communication from the Commission to the Council. The combination effects of chemicals. Chemical mixtures COM(2012) 252 final.

  23. 23.

    Ibid., s. 5.1, (1)

  24. 24.

    Ibid., s. 5.1, (2).

  25. 25.

    The directive was updated in 2013 with 12 new substances (2013/39/EU).

  26. 26.

    There are also EQS referring to a sum of concentrations of selected congeners or isomers of a parent compound: six PBDEs, four cyclodiene pesticides and four DDT isomers.

  27. 27.

    Regulation from the Agency for marine and water management (Havs- och vattenmyndighetens föreskrifter - HVMF 2013:19).

  28. 28.

    Carvalho, R.N., Arukwe, A., Ait-Aissa, S., Bado-Nilles, A., Balzamo, S., Baun, A., et al. “Mixtures of chemical pollutants at European legislation safety concentrations: how safe are they?” (2014) 141 Toxicological Sciences 218–233.

  29. 29.

    This option has also been discussed, e.g. in European Commission Guidance Document No. 27. Technical Guidance For Deriving Environmental Quality Standards (2010).

  30. 30.

    See Commission decision of 1 September 2010 on criteria and methodological standards on the good environmental status of marine waters (2010/477/EC), in the Annex part B, descriptor 8 and the European Commission Commission staff working paper. Relationship between the initial assessment of marine waters and the criteria for good environmental status SEC (2011) 1255 final, 55.

  31. 31.

    HELCOM , 2013. HELCOM core indicators : Final report of the HELCOM CORESET project. Baltic Sea Environment Proceedings No. 136 I. Also OSPAR has produced a guidance document specifically for descriptor number 8. OSPAR - MSFD Advice document on Good environmental status - descriptor 8: Contaminants, a living document – Version of 2 March 2012). Approaches to determining good environmental status, the setting of environmental targets and selecting indicators for Marine Strategy Framework Directive descriptor 8.

  32. 32.

    Ibid.

  33. 33.

    Art. 1.1 REACH .

  34. 34.

    Art. 1.2 REACH.

  35. 35.

    Arts. 6, 7 and 10 REACH.

  36. 36.

    Art. 14 REACH.

  37. 37.

    Art. 14.4 REACH. The exposure assessment includes both the production and use of the substance, as well as the waste stage. For more detail on how an exposure assessment is done and its function on the chemical safety report, see Annex I, section 5 in REACH .

  38. 38.

    Art. 56, REACH .

  39. 39.

    Arts. 60.5 and 61.2(b), REACH.

  40. 40.

    Art. 67, REACH.

  41. 41.

    Art. 68, REACH.

  42. 42.

    ECHA Guidance on registration (2012) ECHA-12-G-07-EN, 14.

  43. 43.

    Cumulative exposure (one substance, all routes ) to the same substance is handled in Annex I (section 6) and ECHA Guidance on Information Requirements and Chemical Safety Assessment. Part E: Risk Characterisation 2016 part E 4.5, step 5.

  44. 44.

    Art. 2.4 in REACH .

  45. 45.

    Art. 61.5 in REACH.

  46. 46.

    Arts. 1.1 and 97, BPR . Substances that are authorised in accordance with directive 98/8/EC can also be authorised in the new BRP (art. 86).

  47. 47.

    The listed biocide products that are covered by BPR need to be approved under BPR but are not subject to authorisation under REACH , Annex V of BPR. Products and treated goods covered by other specific legislative acts, such as the plant protection regulation, are outside the application area of the BPR (art. 2). See the preamble para. 11 in BPR.

  48. 48.

    Arts. 4.1 and 19 of the BPR.

  49. 49.

    Art. 19.5 in BPR .

  50. 50.

    Annex VI paragraphs 67 and 69 in BPR. Approval should not be granted if the product does not fulfil the specific criteria of effectiveness , effects, etc. (art. 19 (iv)).

  51. 51.

    Art. 19, BPR.

  52. 52.

    ECHA Transitional Guidance on mixture toxicity assessment for biocidal products in the environment (2014).

  53. 53.

    Art. 8.3, BPR.

  54. 54.

    Art. 4.1, BPR.

  55. 55.

    This regulation repeals the Council Directives 79/117/EEC and 91/414/EEC. These older directives had few considerations regarding the mixing of several compounds and their potential combination effects . Instead the assessments were based on the properties of individual substances.

  56. 56.

    In art. 2 the area of application is set. Products that affect the lifecycle or serviceability of plants can also be viewed as a plant protection product . The relation between substances regulated in PPR and REACH is described in art. 56.4 (a) and (b) REACH.

  57. 57.

    Art. 1.3, PPR.

  58. 58.

    Arts. 21 and 44.2 PPR. As legal grounds for review, only arts. 4.1(a)(iv) protection from priority hazardous substances, 4.1 (b)(i) protection of groundwater, 7.2 and 7.3 protection of drinking water, in WFD are relevant.

  59. 59.

    See the preamble, para. 3. Linked to PPR is Directive 2009/128/EC, establishing a framework for Community action to achieve the sustainable use of pesticides. The Directive sets provisions for how to use, store and apply pesticides. It complements the WFD and points out the responsibility of member states to avoid certain substances, prioritised according to the WFD (art. 11 in directive 2009/128/EC).

  60. 60.

    Frische, T., Matezki, S. & Wogram, J. “Environmental risk assessment of pesticide mixtures under regulation 1107/2009/EC: a regulatory review by the German Federal Environment Agency (UBA)” (2014) Journal für Verbraucherschutz und Lebensmittelsicherheit.

  61. 61.

    EFSA “Risk assessment for birds and mammals” (2009) 7(12) EFSA Journal 1438 (doi: doi:https://doi.org/10.2903/j.efsa.2009.1438). EFSA “Scientific Opinion: Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters” (2013) 11(7) EFSA Journal 3290 (doi: https://doi.org/10.2903/j.efsa.2013.3290). EFSA “Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)” (2013) 11(7) EFSA Journal 3295 (doi: https://doi.org/10.2903/j.efsa.2013.3295). EFSA “Scientific Opinion addressing the state of the science on risk assessment of plant protection products for non-target terrestrial plants” (2014) 12(7) EFSA Journal 3800 (doi: https://doi.org/10.2903/j.efsa.2014.3800)

  62. 62.

    See Swedish Government Bill 2012/13:35 p. 20.

  63. 63.

    Art. 9.4, IPPC.

  64. 64.

    See art. 9.4, IPPC.

  65. 65.

    Art. 14(3) IED. See the European Commission Joint Research Centre website http://eippcb.jrc.ec.europa.eu/reference/. Under the IPPC directive, the BAT conclusions were called BAT reference documents (BREFs) and had a weaker legal value in the national permit processes.

  66. 66.

    Art. 13, IED.

  67. 67.

    Art. 18, IED.

  68. 68.

    Annex VI (paras. 67 and 69) of BPR .

  69. 69.

    The production, trade and use of DDT was banned between 1970 and 1975 in most countries bordering the Baltic Sea , notably in Scandinavia and the former West Germany. DDT was no longer used in Poland by the mid-1980s, nor in Estonia, Latvia, Lithuania, Russia and the former East Germany by the mid-1990s. See HELCOM , 2010. Hazardous substances in the Baltic Sea: An integrated thematic assessment of hazardous substances in the Baltic Sea. Baltic Sea Environment Proceedings No. 120B, 32–36.

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  1. Department of Law, University of Gothenburg, Gothenburg, Sweden

    Lena Gipperth

  2. Department of Biological & Environmental Sciences, University of Gothenburg, Gothenburg, Sweden

    Thomas Backhaus

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Correspondence to Lena Gipperth .

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  1. Department of Law, Åbo Akademi University, Turku/Åbo, Finland

    Henrik Ringbom

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Gipperth, L., Backhaus, T. (2018). The Lack of Regulation of Chemical Mixtures and Its Legal Consequences in the Baltic Sea Area. In: Ringbom, H. (eds) Regulatory Gaps in Baltic Sea Governance. MARE Publication Series, vol 18. Springer, Cham. https://doi.org/10.1007/978-3-319-75070-5_5

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