CSA/CSR Workshop
Ch. Gründling
15. Jänner 2009; Wien
CSA/CSR im Überblick -Wie weit ist die (chemische) Wirtschaft?
15. Jänner 2009 CSA/CSR - Workshop
CSA/CSR im Überblick
Quelle:
TGD Info.
Req. and
CSA,
Part A,
Fig A.2-1,
Mai 2008
[1]: Schritte in REACH Anhang I[1]: Schritte in REACH Anhang I
15. Jänner 2009 CSA/CSR - Workshop
CSA/CSR im Überblick
• Stoffsicherheitsbeurteilung für alle Verwendungen– ECHA – Leitlinien und deren Verwendung bei der
Durchführung der Stoffsicherheitsbeurteilung
– Systematische Beurteilung der „sicheren Verwendungen
• „Generische“ Expositionsszenarien („Expositionskategorien“)
• „Spezifische“ Expositionsszenarien
• Stoffsicherheitsbericht– Erstellung des Stoffsicherheitsberichts
– Schnittstellen zum technischen Dossier
• Kommunikation in der Lieferkette– Erfassung aller Verwendungen
– Erstellung des „erweiterten“ Sicherheitsdatenblatts
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnershipvia trade associations
Generic ES Development
• Input of DU Associations• Development GES library
M/I and selected DU’s
Specific ES development
• Input of selected customers• Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU• Complete feedback
form• Await decision M/I
Final Exposure Scenario (M/I)
DU• Prepare CSA/CSR• Inform Agency
No
Yes
or
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to direct DU
Distributionof e-SDS
for
sa
fe u
se
s o
nly
1
2
3
4
5Stoffsicher-
heitsbericht
15. Jänner 2009 CSA/CSR - Workshop
Verwendungen; Verwendungsbedingungen
• Übersicht über Verwendungen und Expositionswege
bzw. Expositionsszenarien; Kurztitel
– Basis: REACH-Verordnung Anhang VI Zi. 6
• Hauptverwendungskategorien: industrielle, gewerbliche
(geschlossenes System, Einschluss in oder auf Matrix,
eingeschränkte Verwendung, verbreitete Verwendung) sowie
private Verwendung
• Signifikanter Expositionsweg: Exposition am Menschen (oral,
dermal, inhalativ), Umweltexposition (Wasser, Lift, fester
Abfall, Boden), Expositionsmuster (unbeabsichtigte/seltene
Exposition, gelegentliche Exposition, ständige/häufige
Exposition
– Basis: ECHA Leitlinien: „Use Descriptor“ System
1
15. Jänner 2009 CSA/CSR - Workshop
Use Descriptor (Leitlinien R12) 1
15. Jänner 2009 CSA/CSR - Workshop
Use Descriptor (Leitlinien R12)
• Sector of Use (SU), z.B.
– SU 8 Manufacture of bulk, large scale chemicals (including
petroleum products)
– SU 17 General manufacturing, e.g. machinery, equipment,
vehicles, other transport equipment
– SU 21 Private households (= general public = consumers)
– SU 23 Recycling
• Product Category (PC), z.B.
– PC 7 Base metals and alloys
– PC 9 Coatings and Paints, Fillers, Putties, Thinners
– PC 21 Laboratory Chemicals
– PC40 Extraction agents
1
15. Jänner 2009 CSA/CSR - Workshop
Use Descriptor
• Process Category (PROC), z.B.
– PROC 2 Use in closed, continuous process with occasional
controlled exposure (e.g. sampling); Industrial setting
– PROC 11 Spraying outside industrial settings or applications
– PROC 25 Hot work operations with metals
• Article Category (AC), z.B.
– AC 2 Machinery and mechanical appliances thereof
– AC 8-2 Paper products: newspaper, packaging
– AC 13-3 Plastic products: Toys
– AC34 Scented Toys
– AC39 Other articles releasing grease or corrosion inhibitors;
please specify
1
15. Jänner 2009 CSA/CSR - Workshop
Umwelt – Freisetzung (Leitlinien R16)
• Environmental Release Categories (ERC)
– ERC 2 Formulation of preparations
– ERC4 Industrial use of processing aids
– ERC 8A Wide dispersive indoor use of processing aids in open
systems
– ERC11B Wide dispersive indoor use of long-life articles and
materials with high or intended release
• Diese Kategorien für die Freisetzung in die Umwelt sind
nicht Bestandteil des Use Descriptor Systems,
allerdings beruhen Modelle zur Expositionsabschätzung
(EUSES) in die Umwelt darauf.
1
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnershipvia trade associations
Generic ES Development
• Input of DU Associations• Development GES library
M/I and selected DU’s
Specific ES development
• Input of selected customers• Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU• Complete feedback
form• Await decision M/I
Final Exposure Scenario (M/I)
DU• Prepare CSA/CSR• Inform Agency
No
Yes
or
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to direct DU
Distributionof e-SDS
for
sa
fe u
se
s o
nly
2
15. Jänner 2009 CSA/CSR - Workshop
Expositionsabschätzung – generische Modelle
• Gemeinsamkeit von generischen Modellen
(Stufe 1; Tier 1)
– Basis: intrinsische Stoffeigenschaften
– Beruhen auf Standardvorgaben
– Konservative („worst case“) Annahmen
– Berücksichtigung von allgemein gültigen Hygienestandards
und Verwendungsbedingungen; allerdings ohne spezielle
Risikomanagementmaßnahmen
• Verwendung unter
– Berücksichtigung aller vorgesehenen Verwendungen (PROCs,
PCs sowie ERCs)
2
15. Jänner 2009 CSA/CSR - Workshop
Expositionsabschätzung – generische Modelle
• ECETOC TRA(http://www.ecetoc-tra.org/)
• COSHH Essentials(http://www.coshh-essentials.org.uk/)
• EMKG(http://www.reach-helpdesk.de/
nn_72770/de/Downloads/
EMKG-EXPO-TOOL.xls)
• ConsExpo(http://www.rivm.nl/en/healthanddisease/
productsafety/Kopie_van_ConsExpo.jsp)
• EUSES(http://ecb.jrc.ec.europa.eu/euses/)
2
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnershipvia trade associations
Generic ES Development
• Input of DU Associations• Development GES library
M/I and selected DU’s
Specific ES development
• Input of selected customers• Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU• Complete feedback
form• Await decision M/I
Final Exposure Scenario (M/I)
DU• Prepare CSA/CSR• Inform Agency
No
Yes
or
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to direct DU
Distributionof e-SDS
for
sa
fe u
se
s o
nly
3
15. Jänner 2009 CSA/CSR - Workshop
Kommunikation über Verwendungen
• Kommunikation von Verwendungen über das
Sicherheitsdatenblatt: guter erster Anhaltspunkt (insbesondere
für nachgeschaltete Anwender), aber
– in einigen Fällen nicht sehr aussagekräftig oder nicht vorhanden
– keine Kompatibilität mit „Use Descriptor“ System
• Kommunikation für die Weiterentwicklung von
Expositonsabschätzungen: geordnete und weitgehend
standardisierte Kommunikation notwendig
– für spezifische Verwendungen und Expositionsszenarien notwendig
– Basis: „Use Descriptor“ System ausgehenden vom Lieferanten
(Nachteil: für Laien „erklärungsbedürftig“)
• CEFIC: Entwicklung einer Standards
3
15. Jänner 2009 CSA/CSR - Workshop
Entwicklung des CEFIC Werkzeugs
• Übereilte Kommunikation nicht notwendig
– „Holding letter“
• Fertigstellung des Standard-Werkzeugs
(Q1 – 2009) zur Kommunikaton von Ver-
wendungen und Expositionsszenarien
– Excel-Template
– auf Internetbasis
– Weiterleitungsmöglichkeit in der
gesamten Lieferkette
• http://cefic.org/Templates/shwStory.asp?NID=719&HID=714
3
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnershipvia trade associations
Generic ES Development
• Input of DU Associations• Development GES library
M/I and selected DU’s
Specific ES development
• Input of selected customers• Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU• Complete feedback
form• Await decision M/I
Final Exposure Scenario (M/I)
DU• Prepare CSA/CSR• Inform Agency
No
Yes
or
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to direct DU
Distributionof e-SDS
for
sa
fe u
se
s o
nly
4
15. Jänner 2009 CSA/CSR - Workshop
Expositionsszenarien
Generische ES Spezifische ES
H/I und NA über jeweilige
Wirtschaftsverbände
Iterativer Prozess zwischen H/I und
ausgewählten Kunden (N/A)
Gebräuchliche Verwendungen, z.B.
Gebrauchschemikalien
Spezielle Verwendungen, z.B.
Feinchemikalien
Weit verbreitete Anwendungen Limitierte Lieferkette
Setzt einigermaßen gute Kenntnis der
Stoffverwendung durch den H/I voraus
Verwendung der Kommunikations-
vorlage, wenn wenig Information zur
Handhabung vorhanden ist
Gruppierung von Stoffen mit ähnlichen
Eigenschaften
Einzelstoffe mit speziellen oder
generellen Verwendungen
4
15. Jänner 2009 CSA/CSR - Workshop
Generische Expositionsszenarien
• Beispiel Wasch- und Reinigungsmittel:
4
15. Jänner 2009What should DU do now?
Use reporting in A.I.S.E.: to support suppliers
prepare for registration
Co
nsu
mer
Pro
fessio
nal
A.I.S.E. uses description for Tier-1 assessment (based on Use Descriptor System):
Consumer and Institutional sector; http://www.aise.eu/reach/exposureass.htm
Examples:
for M/I
for A.I.S.E. members
Type of detergent or
maintenance
product
REACH Sector of
Use
Use descriptor
Product Category (PC)
Use descriptor
Process Category
(PROC)
Use descriptor
Environmental
Release Class
(ERC)
Hand Diswashing
Liquid Regular
SU 21 – private
household
PC 35 – Cleaning agents Not applicable 8a – processing aid
wide
dispersive,
indoor
Air Freshener electric
diffusers
SU 21 – private
household
PC 3 – Air care products Not applicable 8a – processing aid
wide
dispersive,
indoor
INSTITUTIONAL
FLOOR CLEANING –
Manual
SU22 – public
domain
PC 35 –Cleaning agents PROC 8 – discharging to/from containers
PROC 10 – roller or
brushing application
8a – processing aid
wide
dispersive,
indoor
PROFESSIONAL
FABRIC WASHING –
Semi Automatic
SU22- public domain PC 35 –Cleaning agents PROC 8 – discharging to/from containers
PROC 2 – Closed
continuous process
with occasional exposure
8a – processing aid
wide
dispersive,
indoor
20
Human Safety Assessment
Consumer• Limited set of RMM
• DNEL lower
• No technical control of handling practices
• Untrained
• Unlimited duration of activity
• To be taken into account vulnerable population as such (children, elderly)
Worker• Prescribed RMM/mandatory PPE
• DNEL = OEL
• Technical control of handling practices possible
• Trained
• Limited duration of activity
Two distinct assessment and communication approaches
21
Environmental Safety Assessment
Two Distinct Types of Uses
Wide Dispersive• End Users : Consumers and
Professionals
• Emissions are not related to a specific location
• Discharge permit required: No
• No technical emissions control
Point Source• End Users: Businesses –
independent of size
• Emissions are related to a specific location
• Discharge permit required: Yes
• Technical emissions control possible
Two distinct assessment and communication approaches
15. Jänner 2009What should DU do now?
DRAFT GES – DRAFT ASSESSMENT
Consumer use of IPA-containing household cleaners
Scope of process Covers general exposures arising from use of IPA in liquid or aerosol household products including household
cleaners, personal cleansing agents
Duration and frequency of use Covers daily exposures up to 2 hours
Environment
Up to 365 days per year
Product specification Covers use of up to 25% IPA
Physical form of product Liquid or aerosol
Maximum amount per time or activity Covers daily exposures up to 2 hours
Other operational conditions of use Human health Assumes no ventilation and a room size > 20 m3, and up to 20 g product per use event.
Environment
All aqueous product is assumed to be discharged to waste water. If waste water is not discharged via public sewer
system, then the capacity of the receiving environment should at least be 1,000 m3/d.
Risk management measures Human health
- Avoid direct skin contact (ConHlth1); for spray products, avoid spraying directly into eyes or nose (ConHlth2).
Environment
- Discharge cleaning water into sewer system (ENVT4). Do not discharge cleaning water directly into small
waters (ENVT12).
Waste related measures Dispose of spillages and used containers according to local regulations.
Prediction of exposure Human health RCR < 1. Estimated consumer inhalation exposure of 83 mg/m3 based upon RIP R15 equations, or dermal exposure of 10 mg/kg/day. (DNEL = OEL/5)
Environment RCR<1, The risk characterisation has been conducted by comparing the ratio of PECs derived from
the EUSES calculation for the local scenario and the PNEC values for the different environmental
compartments based upon PNECs referenced from HERA for IPA, 2005.
Methods to check compliance Human health Calculate if total amount of classified substance per use (product amount X conc. of classified substance in product) is < 2.5 g.
Environment
All product is assumed to be discharged to waste water. If waste water is not discharged via public sewer system,
then the capacity of the receiving environment should at least be 1,000 m3/d.
OK
OK
OK (high)
OK
OK OK (low?)
Meaning for consumer? Good practice, not RCR-driven
OK (low?)
15. Jänner 2009 CSA/CSR - Workshop
Spezifische Expositionsszenarien 4
15. Jänner 2009 CSA/CSR - Workshop
Spezifische Expositionsszenarien 4
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnershipvia trade associations
Generic ES Development
• Input of DU Associations• Development GES library
M/I and selected DU’s
Specific ES development
• Input of selected customers• Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU• Complete feedback
form• Await decision M/I
Final Exposure Scenario (M/I)
DU• Prepare CSA/CSR• Inform Agency
No
Yes
or
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to direct DU
Distributionof e-SDS
for
sa
fe u
se
s o
nly
Stoffsicher-
heitsbericht
15. Jänner 2009 CSA/CSR - Workshop
Stoffsicherheitsbericht
• Datei als Bestandteil der Registrierung in IUCLID 5 im
Format gemäß Anhang I der REACH-Verordnung
Stoffsicher-
heitsbericht
CSRCSR
15. Jänner 2009 CSA/CSR - Workshop
ECHA Werkzeug
• Verwendung der Informationen des technischen
Dossiers zur Erstellung des CSR (Fertigstellung: 2010!)
Stoffsicher-
heitsbericht
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnershipvia trade associations
Generic ES Development
• Input of DU Associations• Development GES library
M/I and selected DU’s
Specific ES development
• Input of selected customers• Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU• Complete feedback
form• Await decision M/I
Final Exposure Scenario (M/I)
DU• Prepare CSA/CSR• Inform Agency
No
Yes
or
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to direct DU
Distributionof e-SDS
for
sa
fe u
se
s o
nly
5
15. Jänner 2009 CSA/CSR - Workshop
e-SDS
• REACH Art 31 (7): „Jeder Akteur der Lieferkette, der
einen Stoffsicherheitsbericht nach
Artikel 14 oder 37 zu erstellen
hat, fügt die einschlägigen
Expositionsszenarien (gegebe-
nenfalls einschließlich
Verwendungs- und Expositions-
kategorien) dem die identifi-
zierten Verwendungen
behandelnden Sicherheits-
datenblatt als Anlage bei …“
• Leitlinien CSA; Teil G
– 9 Abschnitte
5
15. Jänner 2009 CSA/CSR - Workshop
CSA/CSR - Herausforderungen
• Viele unterschiedliche Verwendungen, Expositions-szenarien und Bewertungsmöglichkeiten; aber:– einfache Bewertungsmodelle im Unternehmen meist bereits
vorhanden; guter Ausgangspunkt
– keine konkreten Vorschriften zur tatsächlichen Bewertung, unterschiedliche Einstiegsmöglichkeit; hohe Flexibilität
• Wenig Erfahrung bei der umfassenden Risikobewertung von Stoffen; aber:– Expertise und Informationen in Teilbereichen (Arbeitnehmer-
schutz, Umweltschutz); erster Startpunkt
– Werkzeuge und Expertise nehmen mit der Zeit zu
• Wenig Zeit für CSA/CSR; insbesondere für Stoffe der ersten Registrierungsphase; KEIN „aber“!
15. Jänner 2009 CSA/CSR - Workshop
CSA/CSR – Ein Erfolg!?