1. Enhancing the efficiency of Supply Chain Communication
GPS / REACH workshop
04 Oct 2011
Athens, Greece
L. Heezen
Manager Global Chemical Regulations

2. Agenda Introduction: communication up and down the Supply Chain SDS:
When are they required
Main challenges
ES communication:
REACH Libraries
ESCom phrases
ESCom XML
Chesar

3. Communication down the supply chain
Manufacturers and Importers of a substance/preparation shall communicate how their substances/preparations can be used in a safe way
Safety Data Sheet (SDS) including Exposure Scenarios (ES):
Operational Conditions (OC) and
Risk Management Measures (RMM) under which the substances/preparations can be used in a safe way
If a SDS is not required, the M/I shall communicate key risk information to enable appropriate risk management (article 32)
Distributors to pass on information on safe use to their customers

4. Communication up the supply chain
DU has the right to make their use known to their supplier
DU has the duty to inform his supplier about:
inappropriateness of the received RMM
new information on the hazardous properties of the substance/preparation
Distributors shall pass on the information received from DU to the next actor up in the supply chain

5. Agenda Chesar Introduction: communication up and down the Supply Chain
SDS:
When are they required
Main challenges
Support:
REACH Libraries
ESCom phrases
ESCom XML
Chesar

6. Safety Data Sheet (SDS)
The purpose of the SDS is to provide the user with:
necessary measures relating to protection of human health and environment
information to convey down the supply chain when they are not final user (i.e. to compile the SDS for their own mixtures)
Format of the SDS:
The SDS follows a 16 section format which is internationally agreed.
The SDS must be in the language of the country in which it is placed on the market.

7. Safety Data Sheet (SDS)
SDS are mandatory when:
Substance/mixture is classified as hazardous
Substance is PBT/vPvB
Substance is in candidate list (SVHC) (ECHA website)
On request of recipient: SDS also for preparations not classified as dangerous but containing:
Classified substance > 1%
PBT/vPvB > 0.1%
SVHC > 0.1%
substances limited on workplace
SDS not obligatory for:
general public (but sufficient info on safe use)
Articles (but if SVHC > 0.1 %, communication on safe use to be provided)

8. Safety Data Sheet (SDS)
Communication down the supply chain when no SDS is required:
If a SDS is not required, the M/I shall communicate key risk information to enable appropriate risk management:
If Substance is subject to Authorisation/restriction:
Registration number
Details of granted authorisation or appropriate info if authorisation is denied
Details of restriction
Other available and relevant info on safe use
If Substance is not subject to Authorisation/Restriction:
Registration number (if risk information is provided)
Available and relevant info to assure appropriate RMM

9. Who prepares the SDS? SDS are prepared by competent persons:
Competent Persons are persons – or a coordinator of a group of people - who have, as a result of their training and continued education, sufficient knowledge for the elaboration of the respective sections of the SDS or of the entire SDS.
It is not necessary that the expert knowledge is provided in full by one person.
These duties can be delegated to own staff or to third parties.
Competent persons should be trained regularly

10. How are SDS provided? SDS must be provided free of charge
In an official languages of the recipient’s MS
Electronically by
Posted on website + notification to downstream user to download under discussion (MS opinion is that it needs pro-active action)

11. Registration number in SDS
Structure of registration number:
<TYPE>-<BASE-NUMBER>-<CHECKSUM>-<INDEX-NUMBER>
Issues: confidentiality & workability
This last 4 digits may be omitted:
For substances: by distributor or a downstream user
For mixtures: by any supplier
provided that :
the supplier provides the full registration number upon request to the MS authority within 7 calendar days
if the full registration number is not available to him, a copy of the request must be sent to his supplier within 7 calendar days
Company specific!

12. Safety Data Sheet (SDS)
Consistency with registration dossier
Identified uses
Supplier
Exposure control
Personal protection
Phys-chem properties
Etc…

13. SDS: transitional periods
For substances
1 December 2010 – 1 June 2015:
Format: Annex I of published Annex II*
Classification: DSD + CLP in section 2.1
From 1 June 2015:
Format: Annex II of published Annex II*
Classification: CLP
For Mixtures:
Classification: DPD
* Amendment regulation (EC) No 1907/2006 (REACH)

14. SDS: transitional periods-derogations
Substances placed on the market before 1 December 2010:
if classified, labelled and packaged according to DSD need not be re-labelled or repackaged according to CLP until 1 December 2012.
If not required to be relabelled and repackaged or an update is required, need not be aligned with the new Annex until 1 December 2012.
Mixtures already placed on the market before 1 June 2015:
if classified, labelled and packaged according to the DPD, need not be re-labelled or repackaged according to CLP until 1 June 2017.
if not required to be relabelled and repackaged or an update is required need not be aligned with the new Annex II (second version) until 1 June 2017.

15. SDS: main challenges
New structure of headings and sub-headings: IT softwares to adapt!
Complexity of transitional periods for voluntary/mandatory provisions: several formats & contents co-existing!
Consistency SDS main body with Exposure Scenario Annexes and registration dossier
Different national provisions
Role of formulators: SDS for mixtures

16. Modifications after substance registration: identified uses and exposure scenarios
Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet: Extended Safety DataSheet (eSDS)

17. Extended Safety Datasheet (eSDS)
Modifications after substance registration: identified uses and exposure scenarios
Extended Safety Datasheet (eSDS)
Exposure Scenario: describes safe use of a substance on its own or in a mixture during its life cycle
Process condistions
Operational conditions
Risk Management Measures and waste treatment measures
Exposure estimation and model used
Information for DU to find out if his use is in range of described ES

18. Agenda Chesar Introduction: communication up and down the Supply Chain
SDS:
When are they required
Main challenges
Support:
REACH Libraries
ESCom Phrases
ESCom XML
Chesar

19. REACH Libraries – Objectives
To facilitate availability of information to support the development of Exposure Scenarios across industry
To support consistency and efficiency of Exposure Scenario development
The Libraries are available via the Cefic website

20. Cefic libraries TF: overview
28 sectors included including solvents, coatings, plastics, silicons, catalysts, metals, etc.
Available information: uses, OC’s, RMM’s, GES, templates, etc.
Links to available information
Updated monthly with new information, sectors, etc…

21. The ESCom Package Exposure Scenario Communication = ESCom
Standard for the electronic exchange of ES information in the supply chain.
Developed in two projects:
ESCom Phrases – Standard phrases for Exposure Scenarios – Developed in CEFIC led project
ESCom XML – Electronic exchange standard for Exposure Scenarios – Developed in DUCC led project, Participants: CEFIC, VCI, BDI, IT-Companies (SAP/Technidata, IHS/Atrion, The Wercs, Ariel/3E, Lisam, Kisters, CGI, Safeware, Qualisys, Selerant, UMCO, ESKA …)
Involvement of ECHA to facilitate alignment with CHESAR development.

22. ESCom Package - Products
ESCom XML Rel. 1.1 – The Container for ES Info
XML Schema-definition
ESCom XML guidance document
Technical documentation
Example of an XML-File
ESCom Standard-Phrases - The Content for ES Info
Master-File with standard-phrases (incl. phrase-codes)
Template for phrase proposal submission
Guidance document for phrase development
Chesar XML for ESCom import
All products are freely accessible at

23. ESCom Products Phrase catalog contains some 1800 phrases.
Phrases are consensus phrases.
Phrase codes are aligned with EUPhraC
Phrases are available with phrase codes and metadata (partly).
Continuous process is installed to adopt additional phrases
ESCom XML offers more than 160 data fields.
No possibility to transport free text.

24. What are the benefits?
Automated exchange of Exposure Scenario information replaces manual data entries – avoids retyping.
Standard Phrase codes facilitate transformation of ES into other languages.
Standardized exchange of Exposure Scenario information avoids interpretation errors.
Standardized exchange of Exposure Scenario information leads to steeper learning curve among DUs and enforcement bodies.
Standardised exchange of ES info allows company IT systems to translate the information into company specific lay out without interpretation problems.

25. Agenda Chesar Introduction: communication up and down the Supply Chain
SDS:
When are they required
Main challenges
Support:
REACH Libraries
ESCom phrases
ESCom XML
Chesar

26. Chesar Chemical Safety Assessment and Reporting Tool (Chesar)
Under development by EU Chemicals Agency
Release 1.2 available
Uses Ecetoc TRA for workers/consumers and EUSES for environment as default
Results of other estimating tools can be processed
Helps in the assessment process
Generates some reporting, like CSR chapters
Generates ES for communication

27. Organisation of Chesar
Manage substances
Reporting of uses
Manage assessment
ES building and CSR generation
Generation of ES for eSDS
Administration tools

28. SDS management system by formulators
Chesar and SDS systems
Substance properties info Use info
Use conditions/exposure info
IUCLID
PBT assessment
Chesar
Maps of Uses
External ES
libraries
External Exposure Estimation Tools
CSR
ES for
eSDS
SDS management system by formulators
SDS generation system

29. Chesar is supporting … PBT assessment
description of identified uses with a view to exposure assessment
exposure assessment
description of conditions of use
exposure data
from built-in exposure estimation tools
from external exposure estimation tools and
from sets measured data characterising certain conditions of use
risk characterization
generation of CSR
generation of exposure scenarios for communication

30. Useful links http://www.cefic.org/Industry-support/Implementing-reach/
Cefic website: guidance’s and tools
Cefic library overview
Chesar
Thank you