1 / 54

Assessment of environmental risks of biocides - focus on emission scenarios

EU course on Environmental Exposure Scenarios in Risk Assessment. Assessment of environmental risks of biocides - focus on emission scenarios. EU Regulations and Directives. new chemicals EC Directive 67/548/EEC existing chemicals EC Council Reg. 793/93

alan-flynn
Download Presentation

Assessment of environmental risks of biocides - focus on emission scenarios

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. EU course on Environmental Exposure Scenarios in Risk Assessment Assessment of environmental risks of biocides - focus on emission scenarios

  2. EU Regulations and Directives new chemicals EC Directive 67/548/EEC existing chemicals EC Council Reg. 793/93 pesticides EC Directives 91/414/EEC biocides EC Directive 98/8/EEC veterinary drugs EC Regulation 2377/90 feed additives EC Directive 70/524/EEC food additives 89/107/EEC cosmetics SCP/803/90 packaging material EC Directive CS/PM/1025

  3. Elements of ‘Chemicals Control’ • Data collection and exchange of information • Classification and labelling • Risk assessment • Risk management (a.o. authorisation)

  4. The EU Biocidal Products Directive (1998) • Why ? :Risk Management ! Whereas 1: ‘.. 1993 .. Council .. need for risk management of non-agricultural pesticides ..’ • How ? (1): Authorisation procedure Whereas 4: ‘.. rules for placing on the market .. taking as a condition a high level of protection for humans, animals and the environment ..’ • How ? (2): Risk Assessment Whereas 7, 8, 9, 11; Article 5; Annex VI TGDs: data requirements, risk assessment of active substances, ...

  5. Data evaluation Exposure assessment Effects assessment Data set Single species toxicity data TGD Emissions Extrapolation Distribution EUSES PNEC PEC Risk characterization PEC/PNEC Environmental Risk Assessment: Basic Framework

  6. PRODUCTION FORMULATION INDUSTRIAL PRIVATE USE USE Processing Processing In product In product aid aid SERVICE LIFE WASTE DISPOSAL - Incineration - Landfilling - Recovery Life cycle

  7. Local emission and distribution routes Air Deposition Agricultural Local emissions Grassland soil Volatilization Leaching Sludge application Groundwater Surface STP water Dilution Sedimentation Sediment

  8. Indicative food chains SOIL POREWATER PREDATORS earthworm SURFACE WATER fish

  9. Exposure assessment (results) Protection target PEC __________________________________________ micro-organisms STP effluent aquatic organisms surface water terrestrial organisms agricultural soil sediment organisms sediment predators fish or earthworms __________________________________________

  10. + + fish algae crustacea Aquatic ecosystem ? Effects assessment • laboratory testing(single species; standardised test) • various trophic levels

  11. PNEC derivation (water) DataAssessment factor Short-term L(E)C50 from each of three trophic levels of 1000 the base-set (fish, daphnia, algae) One long-term NOEC (either fish or Daphnia) 100 Two long-term NOECs from species representing two 50 trophic levels (fish and/or Daphnia and/or algae) Long-term NOECs from at least three species representing 10 three trophic levels (normally fish, Dapnia, algae) Field data or model ecosystems case by case

  12. EU TGD: importance of emission estimation • The TGDs were to be revised, and to also incorporate aspects which are specific for risk assessment of biocides • For biocides, the addition of specific emission and exposure scenarios had a high priority (Biocides TM, 1999) • why ? • uses are the most prominent difference with other chemicals • emission has most significant influence on the final outcome of risk assessment

  13. Experience of initial vs. refined RAs UncertaintyFactor __________________________________________ PNEC ± 10 emission rates 10 - > 1000 STP emission estimation < 10 biodegradation in surface water < 10 exposure assessment PEC 10 - > 10,000 __________________________________________

  14. E m i s s i o n S c e n a r i o s

  15. Definition of ESD • An Environmental Emission Scenario Document is: “A set of conditions about sources, pathways, production processes and use patterns that quantify the emissions (or releases) of a chemical from production, formulation, processing, private use (or use in the household) and recovery/disposal into water, air and solid waste” (OECD 2000) • In general, an ESD should cover all aspects of the life-cycle. An ESD may cover only some parts of the life-cycle, if remaining parts are not relevant or covered by another ESD.

  16. New & Existing Substances PRODUCTION FORMULATION Biocidal Products Directive APPLICATION SERVICE LIFE WASTE Life Cycle & Risk Assessment Local & Regional Scale Local Scale

  17. AIR 100 m Wastewater STP Local scale (1 point source for each life cycle stage) Process Next stage of life cycle SOIL

  18. Regional scale (all sources all stages of l.c.) I I I I Production Formulation Industrial use I I I I P I I F I I F F I I P

  19. Process Factors of Importance • Industrial category • Function of substances • Quantity of product • Content in product • Emission factor(s)

  20. Concept of Emission Estimation • Elements: • Description of the industry or use area (‘process’) • Description of the types of substances used and their function in the industry area • Identification of points of release and emission factors • Information on the scale/size of operations • Information on emission control measures • Instruction on how to use the information in ESD • and examples of calculations

  21. Main Source No. of days Water Air Emission factors Tonnage Soil Waste Emission Scenario 1: Tonnage of Substance INPUT: EF Emission factor (-) Tem Number of emission days (d.yr-1) Q Tonnage (tonnes.yr-1) Fms Fraction of the main source (-) Emission = Q * Fms * EF / Tem * 10-3 (kg.d-1)

  22. Emission Factor Emission Scenario 2: Scale of Process INPUT: Qp Tonnage of product (tonnes.d-1) EF Emission factor (-) Qs Quantity of substance (kg.tonne-1 product) Emission = Qp * Qs * EF (kg.d-1)

  23. Emission Scenario 3: Average consumption INPUT: Qi Consumption per inhabitant (l.d-1) Cs Content of the substance in product (kg.l-1) Fpc Fraction of product with substance (-) EF Emission factor (-) Ni Number of inhabitants (-) Emission = Qi * Ni * Fpc * Cs * EF (kg.d-1)

  24. New & Existing substances Biocides A Biocide is a new or existing substance but a new or existing substance is not (always) a biocide • A Biocide has a specific function : • Disinfectant • Preservative • Insecticide, acaricide, avicide, piscicide, . . .

  25. Biocides Biocides (Use Category 39) Biocidal Products Directive 98/8/EG Annex V 23 biocidal product types

  26. EU Biocidal Products Directive 23 Product Types divided over 4 Groups: I DISINFECTANTS & GENERAL BIOCIDES II PRESERVATIVES III PEST CONTROL PRODUCTS IV OTHER BIOCIDES

  27. I DISINFECTANTS & GENERAL BIOCIDES 1 Human hygiene biocidal products 2 Private & public-health area disinfectants and other biocidal products 3 Veterinary hygiene biocidal products 4 Food and feeding area disinfectants 5 Drinking water disinfectants

  28. II PRESERVATIVES 6 In-can preservatives 7 Film preservatives 8 Wood preservatives 9 Fibre, leather, rubber and polymerised materials preservatives 10 Masonry preservatives 11 Preservatives for liquid cooling and processing systems 12 Slimicides 13 Metalworking-fluid preservatives

  29. IIIPEST CONTROL PRODUCTS 14 Rodenticides 15 Avicides 16 Molluscicides 17 Piscicides 18 Insecticides, acaricides & products to control other arthropod species 19 Repellents and attractants

  30. IV OTHER BIOCIDES 20 Preservatives for food or feedstocks 21 Antifouling products 22 Embalming and taxidermist fluids 23 Control of other vertabrates

  31. PRODUCTION FORMULATION PRIVATE USE SERVICE LIFE WASTE Example 1 Pt 1 : Human Hygiene Biocidal Products • For example: • Deodorants, antiperspirants • Anti-dandruff shampoo • Antimicrobial soap • Etc. • Skin application • Short term • Bathing

  32. Example 1 Pt 1 : Human Hygiene Biocidal Products Emission Scenarios of New & Existing Substances a) Tonnage b) Average consumption per inhabitant

  33. Example 2 Pt 3 : Veterinary Hygiene Biocidal Products 3.1 Disinfection of animal housing 3.2 Disinfection of footwear and animals’feet 3.3 Disinfection of milk extraction systems 3.4 Disinfection of means of transport 3.5 Disinfection of hatcheries 3.6 Disinfection of fishfarms

  34. PRODUCTION FORMULATION APPLICATION SERVICE LIFE WASTE Example 2 Disinfection of animal housing “ ” “ ”

  35. Time No. of cows Moment of manuring Maximum per ha N / P2O5 Example 2 Disinfection of animal housing

  36. EUBEES The EUBEES projects • In 1999, a number of EU Member States, the European Chemicals Bureau and the European chemical industry (CEFIC), and supported by the European Commission, set up the EUBEES working group to develop environmental emission scenarios for environmental risk assessment of biocides in the framework of the Biocidal Products Directive. • EUBEES 1 project: January 2000 until June 2001 • EUBEES 2 project: January 2002 until November 2003

  37. EUBEES 1: Results (1) • Report ‘Development of emission scenario documents for 23 product groups of the EU biocidal products directive 98/8/EG’, INFU/UBA, D. • ‘Emission scenario document for product type 2: private and public health area disinfectants and other biocidal products (sanitary and medical sector)’, RIVM, NL. • ‘Emission scenario document for biocides used in paper coating and finishing (product type 6,7&9)’, INERIS, F. • ‘Emission scenario document for biocides used as preservatives in the leather industry (product type 9)’, INERIS, F.

  38. EUBEES 1: Results (2) • ‘Emission scenario document for biocides used as preservatives in the textile processing industry (product type 9&18)’, INERIS, F. • ‘Emission scenario document for biocides used in taxidermist and embalming processes (product type 22)’, INERIS, F. • Report ‘Proposal for the formats of names, parameters, variables, units and symbols to be used in emission scenario documents’ , RIVM, NL.

  39. EUBEES 2: objectives and results (1) 1 Development of harmonised ESDs: PT 11: preservatives liquid cooling & processing PT 12: slimicides PT 13: metal working fluid preservatives [PT 21: antifouling products (in OECD)] 2 Check ESDs for existing substances on their suitability for biocides: PT 1: human hygiene biocidal products PT 6: in-can preservatives PT 7: film preservatives PT 9: fibre, leather, rubber, polymerised material pres.

  40. EUBEES 2: objectives and results (2) 3 Provide a framework for EU discussion and agreement of new ESDs developed by the members, eg.: PT 5: drinking water disinfectants PT 10: masonry preservatives PT 14: rodenticides PT 18: insecticides (in stables and manure) 4 Test the scenarios for wood preservatives developed by OECD and rodenticides developed by the Nordics in the framework of EUBEES, primarily with regard to usability.

  41. OECD ESD on antifouling products • Antifoulants: inhibit growth of organisms on ship hulls, fishing nets, marine structures. (several definitions!) • Aim: OECD-wide harmonisation of available emission scenarios for anti-fouling applications. • Most antifoulings, ie. 95% are used on ship hulls. Almost all available scenarios deal with the estimation of releases of antifoulings during the service life. • The EESAF steering group will have its third meeting in November 2003. The draft ESD is intended to be finalised early 2004 and submitted to the OECD JM end 2004.

  42. ESDs for Main Group 1 (disinfectants) • PT 01: Human hygiene biocidal products  (RIVM, EUBEES2) • PT 02: Private and public health area disinfectants • Medical equipment  (EU) • Accomodation  (RIVM) • Industrial areas  • Swimming pools  (RIVM) • Air-conditioning  • Chemical toilets  • Wastewater treatment  (RIVM) • Hospital waste 

  43. EUBEES ESDs for Main Group 1 (disinfectants) • PT 03: Veterinary hygiene biocidal products () (RIVM) • PT 04: Food and feed area disinfectants  • PT 05: Drinking water disinfectants ( ) (UBA  EUBEES 2  CA)

  44. ESDs for Main Group 2 (preservatives) • PT 07: Film preservatives • Paints & coatings (PT 06)  • Plastics (PT 09)  • Glues & adhesives  (RIVM) • Paper & cardboard  (RIVM) • PT 08: Wood preservatives  (OECD)

  45. ESDs for Main Group 2 (preservatives) • PT 09: Fibre, leather, rubber & polymer pres. • Textiles & fabrics  (EU) • Leather & hides  (EU) • Paper & cardboard  (EU) • Rubber, polymers, etc. • PT 10: Masonry preservatives () (EUBEES 2  CA)

  46. ESDs for Main Group 2 (preservatives) • PT 11: Preservatives for liquid cooling & processing systems • Cooling systems () (EUBEES 2  CA) • Processing water & liquids • PT 12: Slimicides • Paper & pulp () (EUBEES 2  TM) • Mineral oil extraction () (EUBEES 2  TM) • PT 13: Metalworking-fluid preservatives () (EUBEES 2  CA)

  47. ESDs for Main Group 3 (pest control) • PT 14: Rodenticides () (DK  EUBEES 2  CA) • PT 15: Avicides () (F  EUBEES 2  TM) • PT 16: Molluscicides • PT 17: Piscicides E = c pond

  48. ESDs for Main Group 3 (pest control) • PT 18: Insecticides, acaricides and products to control other arthropods • Manure & stables () (RIVM) • Refuse dumps • Fumigants  (RIVM) • PT 19: Repellents and attractants

  49. ESDs for Main Group 4 (other products) • PT 20: Preservatives for food & feedstocks • PT 21: Antifouling products () ongoing • PT 22: Embalming and taxidermist fluids  (EU) • PT 23: Control of other vertebrates

  50. EU Risk Assessment TGD new version • Harmonised Approach to Risk Assessment of • New Chem, Existing Chem and Biocides • Harmonised Approach to Risk Assessment in the • Marine Environment (N.E.B. and OSPAR) • Include in Guidance what has been learned in the • Existing and New Chemicals areas • Include specific guidance for Biocides • (i.e. emission scenarios!) • Reducing discussion time and disagreements • through increasing the extent of guidance http://ecb.jrc.it > documents

More Related