Exposure scenarios, main
challenges and solutions for
different steps in the chain
4th Annual Conference on
Exposure Scenario
01 March 2016
Mercedes Viñas
European Chemicals Agency
Supply chain communication: why is it
needed?
Manufacturer
Downstream user
Knows the properties of the
substance
– Physico-chemical
– Toxicological
– Ecotoxicological
Knows how the substance is
used
– Operational conditions
– Applied risk management
measures
– Foreseen products
– Concentrations…
Substance properties + conditions of use =
assessment of safe use
2
Supply chain communication: a key
feature in REACH
Further regulatory
action
Access to nonconfidential
information
Authorities
General public
Manufacturers/
Importers
Information on uses
of the chemicals up
the supply chain
Formulators
End-users of
chemicals
Assessment of the potential
risks for all known uses
Helpful information on
safe use down the
supply chain
3
SDS
and
Exposure Scenarios
Substance-specific
information
• Properties and classification
• Regulatory information (e.g.
registration number)
• Overview of registered Uses
• …
• Format: 16 sections
harmonised at global level
(GHS)
–
–
–
–
–
Use-specific information
Operational conditions
Risk management measures
Exposure estimations (if
relevant for recipient/DU)
…
Format: recommended 4
sections format (templates
and examples available on
ECHA website)
SDS + ES = extended SDS
4
How is it working? challenges
• Unstructured communication up the supply chain
• Extended SDS are often ‘too extended’
• Lack of format for Exposure Scenarios
• Information down the supply chain perceived as
difficult to use/process
Supply chain communication identified as one of the
points for improvement in REACH Review 2013
5
How is it working? solutions
ECHA and Stakeholders decided to work together to
address challenges:
CSR/ES Roadmap is a joint action plan towards
2018 (http://echa.europa.eu/csr-es-roadmap)
Exchange Network on Exposure Scenarios
(ENES) meets twice a year to discuss and identify
good practices (http://echa.europa.eu/enes)
6
Different challenges and solutions for
different parts of the supply chain
Authorities
General public
Manufacturers/
Importers
Formulators
End-users of
chemicals
7
Sector use maps
Challenge: unstructured communication on uses up and
unrealistic ES down in supply chain
Solution: use maps
Description of common uses and conditions of use agreed at sector
level
Includes input to CSA:
SWED
Sector Use Maps
Workers
•
Worker/SWED:
•
SCED
INFORMATION
FOR
REGISTRANTS
•
Consumer/SCED:
•
Consumers
•
SpERC
Specific Worker Exposure
Description
Specific Consumer Exposure
Determinant
Environment/SpERC:
•
Specfic Environmental
Release Category
Environment
8
Sector use maps (cont.)
Benefits for all!
Manufacturers
Structured information in a way that can be used as input for
CSA
Overview of common uses (less risk to miss out)
Avoids unnecessary contacts with individual customers
Standard phrases already selected
Downstream users
Harmonised ES from different suppliers on the same use
Based on realistic conditions
ES based on standard phrases
Easier to recognise e.g. ES name
9
ES template
Challenge: lack of defined format for ES
• Annotated templates and ES example available
• Follow recommended 4-sections format
Manufacturers to decide what to include in the ES
for communication and in which format
Downstream users to understand what to expect in
each ES section
http://echa.europa.eu/support/guidance-on-reach-and-clpimplementation/formats
10
ESCom
Challenge: processing ES information received in pdf,
word formats
Solution: ESCom package for electronic sending of
Exposure scenarios in the supply chain :
• Catalogue of standard phrases
• XML format for ES
11
ESCom (cont.)
Benefits both Manufacturers and Downstream
users :
Standard phrases:
same text across companies
supports translations
XML format:
avoids manual typing of ES into company systems
allows processing of ES information
12
ESCom (cont.)
• Release 2.1 in January 2016
• Two releases per year of ESCom catalogue
• XML format frozen for two years to support
implementation
• Contact your IT provider to discuss
implementation!
13
Structured Short titles
Challenge: finding relevant ES in long ext-SDS
Solution: structured short titles
• Used for Table of content between SDS and ES
• Allows DU to quickly identify relevant ES
• Built from use descriptors following agreed rules:
• Life cycle stage
• Market information: PC/AC, SU
• Additional information (if necessary)
E.g. Use at industrial sites; manufacture of fine chemicals;
closed process
http://www.ducc.eu/documents/StructuredShortTitles%20for%2
0publication%20041114%20final.pdf
14
Chesar
Challenge: complex CSA process
Solution: Chesar
• ECHA IT tool for CSA and ES
• Supports CSA process with step-by-step approach
• Consistency between:
• IUCLID and CSR
• CSR sent to authorities and ES communicated in supply
chain
• Facilitates updates
• Free and easy to install
https://chesar.echa.europa.eu
15
Chesar (cont.)
Chesar allows the use of:
• Standard phrases
• Exposure assessment inputs
• ES format
New version 3 to be released in April 2016!
• Extended to cover more complex substances
• Improvements to assessment
• More training planned, stay tuned!
https://chesar.echa.europa.eu
16
Formulators
Challenge: how to combine information and produce a useful
format for end users
Supplier 2
Substance A
Supplier 3
Substance B
Mixture C
Supplier 1
Substance A
What to
communicate
and how?
Mixture D (=A+B+C)
17
Safe use information of
mixture (SUMI)
• Generated at sector level for
common uses
• Simple 1-2 pages format for
end users
• Harmonised content
• Use of pictograms
18
Lead Component
Identification method
• Identification of lead component in
the mixture
• Combination of risk management
measures for these substances =
safe use information on mixture
• Harmonisation from the top will
help
1
2
3
19
eGuide on safety data sheets
and exposure scenarios
Challenge: understand the received ext-SDS
Solution: eGuide
•
Aimed at recipients of extended
safety data sheets
• Workers
• Environmental, health and
safety managers
•
Examples of SDS and exposure
scenario
•
How to understand and use
them
http://view.pagetiger.com/ECHAeG
uide1-1/Issue1
20
Authorities: screening
• Screening of all available data to identify cases of
concern
• Allocate identified substances to the appropriate
follow-up regulatory process
• Interest in Wide dispersive uses:
• widespread (used at many sites, by many
users) and
• potential for release to environment and/or
potential for human exposure
Appropriate use and exposure information in
registration dossiers ensures meaningful screening
21
Authorities: enforcement
• Enforcement is a competence of each EU country
• Coordination via Forum for Exchange of Information
on REACH/CLP Enforcement
• REACH-EN-FORCE (REF) coordinated enforcement
projects across EU
REF-5:
Focus on generation and communication of
Exposure Scenarios
Inspections to be carried out in 2017
22
Key messages
• Information in the supply chain – what goes
up, comes down
• Harmonisation and standarisation are key.
Initiatives are underway under CSR/ES
Roadmap
• Follow the developments, get involved!
http://echa.europa.eu/csr-es-roadmap
Thank you!
[email protected]
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