Differences to environmental risk assessment of chemicals

1
Differences to environmental risk assessment of
chemicals
Seminar for BG MoEW Sofia, 20 April
2006 Elisabeth Fassold Expert Centre Biocides
2
TGD and TNsGs

• TGD
• Methods principles of risk assessment of
• new and existing substances, including
• substances of concern in biocidal products, and
  including
• active biocidal substances
• Result ? RA-based concern conclusions Y/N,
  risk reduction measures or future regulatory
  decisions
• TNsGs
• Specifics of risk assessment of active biocidal
  substances for Annex I, IA, IB inclusion (e.g.
  testing strategies)
• Common principles for RA and a/r of biocidal
  products
• Efficacy and benefits arising from the use
• Result ? RA-, efficacy and benefits-based
  decisions Y/N, conditions, comparative assessment

3
Data requirements ENV exposure assessment

• Quantitative (or qualitative) emission estimation
• new and existing (chemical) substances
• IC-ESDs, emission factors, EUSES
• Core data set (Annex VIIA DSD) on fate and
  behaviour
• PEC derivation or qualitative estimation as in
  TGD
• new and existing biocidal substances
• PT-ESDs, leaching some IC-ESDs EUSES for some
  PTs where not available, emission factors
• Extended fate and behaviour data
• PEC derivation or qualitative estimation as in TGD

4
EUSES for certain biocidal PTs

• Scenarios incl. in EUSES
• Formulation
• (2) Disinfectants
• 2.2 Sanitary sector
• Industrial use
• (2) Disinfectants
• 2.5.1 Medical, disinfectants in
  accommodations
• 2.5.2 Medical, instruments
• 2.5.3 Medical, laundry
• (6) In-can preservatives
• 6.4.1 Paper production
• (7) Film preservatives
• 7.4 Paper and cardboard
• (9) Fibre, leather, paper preservatives
• 9.1 Textile and fabrics
• 9.2 Leather
• 9.4 Paper and cardboard
• (12) Slimicides

(13) Metal working fluids (22) Embalming and
taxidermy 22.1 Taxidermy 22.2
Embalming Private use (2) Disinfectants
2.2 Sanitary sector Service life (9) Fibre,
leather, paper preservatives 9.1 Textile
and fabrics Waste treatment (6) In-can
preservatives 6.4.1 Paper production (7)
Film preservatives 7.4 Paper and
cardboard (9) Fibre, leather, paper
preservatives 9.4 Paper and cardboard
5
Data requirements ENV effects assessment

• new and existing (chemical) substances
• Minimum data set base set as in DSD Annex VIIA
• Usage of all available data (existing substances)
• Covers substances of concern
• new and existing biocidal substances
• Core data set as in BPD Annex IIA
• Additional data requirements PT- and use-specific
  as in TNsG Data Requirements, ch. 2.5, based on
  BPD Annex IIIA
• Key-study concept
• Additional guidance on data requirements for
  substances of concern

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Risk assessment outcome
7
Existing SubstancesStep IV Risk reduction

• A risk reduction strategy has to be elaborated by
  MS in case of conclusions iii)
• Examples of recommended measures are
• Restrictions according to Dir 76/769/EEC
• Community Workplace Exposure Limit Values
• Inclusion into Annex X of the WFD 2000/60/EC
• Publication in EU Official Journal as a
  Commission Recommendation together with the
  results of the risk assessment

8
Existing Substances
Development of a Risk reduction Strategy

• Identify which specific stages of the substances
  life cycle give rise to risks which need to be
  limited (based on RA)
• Identify the options available for risk
  reduction, taking into account of any existing
  RRM)
• Identify the right (legal) tools with which any
  recommended action can be taken
• Select the most appropriate strategy
• (criteria effectiveness, practicality, economic
  impact, monitorability)
• Analyse advantages/drawbacks if MU restrictions
  are recommended
• Submit to the Commission

9
SNIF, IUCLID, CA report

• new (chemical) substances
• Risk Assessment is part of SNIF
• existing (chemical) substances
• Use of IUCLID as effects database
• RMS Risk Assessment CA version is part of IUCLID
• new and existing biocidal substances
• Use of IUCLID as effects database overview
• RMS Risk Assessment equals CA report
• Participants, but no CA version of IUCLID