1. No category

How to use REACH Information for Health and
Safety at Work
The Safety Data Sheet
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Overwiew
-
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New information from REACH for OSH
SDS as information tool, new requirements under REACH
Specific information requirements in Art. 32 , Art. 33, Art. 34
Recent adaptions of SDS provisions by Reg.(EU) 453/2010
Guidance for extending the SDS
Questions from Announcement 409
- identified use
- compliance with operational conditions
- ES-format, scaling
- overprotective ES
- ES and CAD
- PPE
- SDS without annex
Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
(s3)
(s 4,5,6)
(s 7,8,9)
(s 10)
(s 11)
(s 12)
(s 13,14)
(s 15)
(s 16,17)
(s 18)
(s 19)
(s 20)
(s 21,22)
REACH generates Information
(Art.6)
Registration to be submitted from 1t/a and manufacturer
New:
(Art.10)
Information resulting from registration
-
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Safety assessments
performed by
manufacturers
Identified uses (incl. manufacture)
Substance information from tests (tests depending on tonnage)
C&L
Guidance on safe use (CSR or according to annex VI(5), consistent with
section 4,5,6,7 of SDS plus 8,10,13 of SDS if there is no CSA required
CSA and CSR for substances >10t/a and manufacturer (without
prejudice to Art. 4 of Directive 98/24) (Art. 14)
for dangerous substances: exposure- and risk assessment,
resulting in exposure scenarios
Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
How to pass on downstream
the new REACH Information?
First idea:
Pass on Chemical Safety Report
But:
too much paper and additional bureaucracy for DU
Better idea: use SDS
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SDS is an existing instrument for information transfer
SDS structure covers information generated under REACH
New REACH information is „condensed“ in the Exposure Scenarios ,
which could be attached as an annex to the SDS
Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
SDS Requirements included in REACH
Directive 91/155/EEC repealed (1.7.2007)
Art.31 :
former SDS Directive amended by REACH specific elements
The actor in the supply chain who is required to to carry out a CSA (Art. 14 or 37)
shall ensure, that the information in the SDS is consistent with the CSA
shall place the relevant ES in an Annex of the SDS
Any downstream user
shall include ES and use other relevant information when compiling his own SDS
(for identified uses)
For uses of substances that are not
identified by manufacturer see Title V
Annex II:
Annex I of Directive 91/155/EEC, sufficiently amended by
REACH requirements
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
SDS have some specific features in the context
of REACH
SDS:
SDS must be provided for any volume placed on the market
(most REACH requirements depend on tonnages)
SDS must be provided by any member of the supply chain and distributers
(while REACH mostly adresses manufacturers and importers)
SDS are only provided if a substance or mixture is placed on the market
(while REACH also adresses manufacture and import)
SDS are only provided if specific (dangerous) properties apply
(while REACH-registration adresses any substance)
SDS are provided for Substances and mixtures
(while REACH adresses only substances and substances in mixtures,
but not mixtures as a whole)
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
SDS are not the only information in the supply chain
Specific provisions also in Art. 32, 33 and 34
For Art. 32 see Question 5.1 of Announcement 409:
For what kind of hazardous substances will the employer in future
receive "any available and relevant information" according to Article 32
of the REACH Regulation?
- for dangerous substances not classified as dangerous but still conveying
risks (e.g. asphyxiant gases or cryogenic liquids).
- for substances that are not classified because testing has been “waived”.
- for substances subject to authorisation or restriction
these will normally have SDS
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
SDS are not the only information in the supply chain
Specific provisions also in Art. 32, 33 and 34
For Art. 33 see Question 5.5 of Announcement 409:
What information on articles does the employer receive?
Any supplier of an article has to inform his recipient (not a consumer)
–
about > 0.1 % of SVHC substances in the article
–
provide sufficient information for safe use of the article
–
as a minimum, the name of that substance
–
no prescribed format
The majority of dangerous substances set free in the workplace
(from articles or chemicals) is not covered
The employer must gather additional information for risk assessment
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
SDS are not the only information in the supply chain
Specific provisions also in Art. 32, 33 and 34
For Art. 34 see Section 4 of Announcement 409:
Risk management measures according to the safety data sheet vs.
protection measures according to (workplace) risk assessment
If the downstream user who uses a substance or mixture
calls into question the appropriateness of the risk management
measures described in the safety data sheet for an identified use, he
has to pass on that information to the next actor up the supply chain.
He shall also pass on new information hazardous properties
He need not react to any
inconsistencies in SDS
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Art.34 applies also to mixtures,
not only to substances!
Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Art.34 applies to all SDS
not only to eSDS
Recent changes in SDS provisions:
Regulation (EU) 453/2010
Aims:
Adaption to CLP 1272/2008
Adaption to Annex 4 of GHS
„GUIDANCE ON THE PREPARATION OFSAFETY DATA SHEETS (SDS)“
Little (or no?):
new information with relevance to employers
No details on eSDS:
format and contents of the extension of the SDS
is developed in Guidance Documents and IT-tools
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Guidance and tools for extending the SDS
Announced for 2011, will
not deal with extension
http://chesar.echa.europa.eu/documents
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Announcement 409
http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/TRGS/pdf/Announcement-409.pdf?__blob=publicationFile&v=2
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
What is the respective meaning of the terms "use" and
"identified use"?
Question 1.6 of Announcement 409
Both terms are defined in Article 3 of the REACH Regulation.
•
Regardless registration or not, the uses of the substance/mixture
have to be listed under 1.2 of the SDS
•
Only those that are relevant to the recipient of the safety data sheet.
•
There is no prescribed system for the description
•
For extended SDS (eSDS) information in 1.2 must be consistent with information
in the annexed ES
New in Regulation (EU) 453/2010 :
„identified use is“ the only term, uses advised against included in 1.2
Draft Guidance on SDS proposes to indicate whether use advised against
•
•
•
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is statutory (relevant for Art. 37 for substances with CSA)
non statutory on the basis of Annex VI 3.7 (registered without CSA)
non statutory recommendation (technical reasons and/or mixtures)
Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Identified use defined by Use Descriptor-System
Guidance R12 (new version March 2010)
Example Toluene
1. Verwendungsbereich(SU)
new:
Möbelherstellung SU18
24ERCs
plus
ggf.
spERCs
Beschichtungen,Verdünner
PC9a
3. Prozesskategorie (PROC)
Hier:
ERC4
ind. use
not
becoming
part
of articles
2. Produktkategorie (PC)
Industrielles Sprühen PROC7
4. Artikelkategorie (AC)
nicht relevant,Stoff bleibt nicht im
Erzeugnis
REACH-Guidance on information requirements and chemical safety assessment
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
How can it be checked whether the operational
conditions (OC) of the exposure scenario are fulfilled?
Question 1.6 of Announcement 409
Operational conditions are described by
- several parameters for exposure
(e.g. amounts used, concentration, temperature, frequency) and
- additional risk management measures
differing conditions may be compensated
by changing parameters or measures:
“scaling” is described in the guidance on REACH
(Guidance on Information Requirements Part G „Extension of SDS“, Appendices 1-2).
advice on scaling
and tools or methods used for the preparation of the ES and are included in the
last section of the ES (Guidance on Information Requirements
Part D „Exposure Scenario Building“ D 8.2 „Advice to DU”
See next slide
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
„Scaling“ will hopefully
solve most problems
Format for ES according to most recent Guidance
Part D: Exposure Scenario Building und Part F: CSR Format
Draft Update of ExposureScenario Format version 0.2.), 21.03.10
http://guidance.echa.europa.eu/docs/draft_documents/Inforeq_CSR_D_ESformat_draft_update_v2.pdf
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Practial Example for section 4 of ES in eSDS
(most recent format, commercial SDS compiled in 10/2010)
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
What to do, if the use is identified
but the exposure scenario is overprotective?
Under CAD:
perform a risk assessment
and continue use under less protective conditions (obey STOP-principle)
most actors must
comply with both
regulations
Under REACH:
Apply Art. 34 b) ?
Call into question the risk management measures and ….
continue use under less protective conditions ?
Apply “scaling” ?
remove all measures form exposure assessment model and hope that the risk ratio will suffice?
Apply Art. 37 1 ?
Define different conditions as “different use” and ask supplier for a new ES?
Apply Art. 37 4 ?
Perform a Downstream user CSA including duty to report to ECHA according to Art. 38?
„Scaling“ would be most convenient
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Do the protection measures described in the eSDS / ES
render one's own risk assessment superfluous?
Question 2.4 of Announcement 409
No, but the exposure scenario provides valuable information
•
it may be used as a risk assessment supplied with the product (RAS)
if it meets
•
•
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the requirements set out in Annex 2 to technical rule TRGS 400
which is a checklist for whether the information in the sSDS is
sufficient for a RAS
Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Does the SDS contain all the necessary
information for the selection and use of personal
protective equipment (PPE)? Question 2.10 of
annoncement 409:
No.
In the exposure scenario the existance and performance of
PPE is supposed and used in model calculations
Concrete and detailed information must be given in the
body of the SDS (section 8)
In addition
Information on cleaning, maintenance and storage of the
PPE has to be obtained from the PPE supplier, from the
technical rules and from the accident insurance funds.
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Why does my safety data sheet have no annex?
Question 1.4 of Announcement 409
An Annex to the SDS, containing an ES must only be provided for registered
substances that have undergone a CSA that has resulted in one or more
exposure scenarios
Only who is required to prepare a chemical safety report according to Art.14
or 37 shall place the relevant ES in an annex to the SDS (eSDS)).
DU who are not required to prepare a CSA (using substances supplied from
within the EU for their identified uses) shall include the exposure scenarios
they have received and add other relevant information in their own SDS (Art.
31(7)
These DU may either submit the relevant information in the SDS itself (notably
headings 7 and 8) or place the requirements for safe handling in an “ES”
annexed to his SDS.
This not an ES as defined in Art 3,27.
Deviation from this „ES“ is not relevant for Art. 37(4).
It may be relevant under CAD
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Note: Most questions and answers of Announcement 409
(especially those about ES) apply to substances only
An intended Annex Ib describing CSA for mixtures has been removed
from the REACH Regulation because of lack of scientific basis:
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Any Questions ?
Thanks for your attention !
[email protected]
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Backup
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
„Contributing Exposure scenario“
http://guidance.echa.europa.eu/docs/draft_documents/Inforeq_CSR_D_ESformat_draft_update_v2.pdf
Compose one exposure scenario from different contributing
scenarios:
e.g. industrial spray painting
• one (or more) scenarios related to environment
• one or more scenarios related to human exposure
with
contributing scenarios for different tasks and various conditions
•Mixing and filling of equipment (manually) or (automated)
•cleaning the equipment (manually) or (automated)
•manual spraying with (LEV) and no respiratory/skin protection
•manual spraying without LEV, but respiratory/skin protection applied
•robot-spraying (closed-automated)
•conditions during drying of coated article closed or open-ventilated
•conditions during drying of coated article

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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
Content and structure of Information in CSR und
eSDB – similar but not identical
Which information from the CSR-ES to communicate down the supply chain?
• For some of the sub-headlines there may be no OC or RMM or
parts of information compiled in section 9.1 of the CSR
may not be relevant for downstream users.
• How to express the advice to downstream users in standardised phrases?
• Which information from exposure estimation (section 9.x.2 of CSR)
and risk characterisation (section 10.x of CSR
to communicate via e-SDS to the downstream user ?
• Suitable layout of the eSDS-ES may depend on markets,
methods of exposure assessment and/or
amount of information under different subheadlines
http://guidance.echa.europa.eu/docs/draft_documents/Inforeq_CSR_D_ESformat_draft_update_v2.pdf
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin
The format (or parts of it) of ES substances might be also used
when ES from different substances are merged to compile SDS for
mixtures
Art. 31(7) verlangt, dass beim Erstellen eines eigenen SDB die erhaltenen
Expositonsszenarien und andere Informationen einbezogen werden.
Das „Format“ des angehängten ES kann hierzu genutzt werden und
wurde inzwischen angewandt auf
• Cleaning products
• Decopainting
• Epoxyresin flooring
.
Das
„F
Kan ormat“
na
für Z
ube uch
re
gen
utzt itunge
n
wer
den
Nötig bei Zubereitungen:
Bestimmung der kritischen (risikobestimmenden)
Komponente(n) einer Zubereitung
In RIP 3.5.2 „Downstream User requirements“Chapter 14
„Information on preparations to be delivered by formulators“
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Dr. Eva Lechtenberg-Auffarth - How to use REACH Information for Health
and Safety at Work - 6. December 2010, Berlin