Overview on regulatory environm

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This document discusses the regulatory challenges of standardizing safety data sheets (SDS) across different legal areas. It identifies differences in national chemical inventories, restricted substances lists, and SDS template requirements. Specific SDS sections like headings, languages, contents, and annexes vary between places like the EU and US. The document proposes using the EuPhraC structure within SDSComXML, but expanding it to accommodate regulations from other jurisdictions. It suggests standardizing some sections by legal area, like substance names or chemical safety assessments.

Technology

SDScomXML
1
Overview on regulatory environment
with impact on SDSCom
(C) eSDScom Alliance UG, www.esdscom.eu
Licensed under CC-BY-SA 4.0:
http://creativecommons.org/licenses/by-sa/4.0/

SDScomXML
Part I:
EuPhraC structure correlation to SDSCom

SDScomXML
Challenges
1. National chemical inventories and REACH-like regulations
2. National lists of banned chemicals, restrictions and authorizations
3. National GHS (C&L rules, chemical lists with legal C&L)
4. National SDS templates and specialities (e.g. ext. SDS in EU)

SDScomXML
Safety Data Sheet (SDS)
general topics with relation to legal areas
1. Header and sub-header, e.g.
„Safety data Sheet according ….“
„Classification according to …..“
2. Languages, e.g.
„EU-ES (European Spanish)“
„MX-ES (Mexican Spanish)“
3. Different contents, e.g.
„SECTION 1, 2, 8, 11, 12, 13, 14, 15“ (see next slide)
4. Special annexes, e.g.
„Exposure scenarios“ in Europe  ESCOM

SDScomXML
Safety Data Sheet
Overview on specific topics with relation to legal areas
SECTION 1: product identifier and poison centre information
SECTION 2: classification and labelling
SECTION 3: hazardous ingredients
SECTION 8: workplace and biological threshold limit values
SECTION 11: special toxicological information, e.g. IARC (USA)
SECTION 12: special ecotoxicological information, e.g. EU
SECTION 13: special information such as EU-waste codes catalogue
SECTION 14: land transport information such as DOT (USA)
SECTION 15: downstream regulations and national inventory status

SDScomXML
SECTION 1 (EU)
EuPhraC
SDSComXML (not yet assigned)
Are there other legal area specific fields to be implemented?
Input via EuPhraC proposal tool.

SDScomXML
SECTION 2 (EU)
EuPhraC
SDSComXML
Expansion to other SDScom path required such as:
- UNClassfication
- HCSClassification
- AU-GHSClassification

SDScomXML
SECTION 3 (substances and mixtures)
EuPhraC
SDSComXML
Legal area specific modification required?
SubstanceNameEU
Expansion to other SDScom path required such as:
- SubstanceNameUS
- SubstanceNameCN
- SubstanceNameCD

SDScomXML
SECTION 12 (EU)
EuPhraC
SDSComXML
New name of the path?
ResultsOfPbtVpvbAssessmentEU

SDScomXML
SECTION 15 (national regulations)
EuPhraC
SDSComXML
Better split-off in other legal areas?
- NationalLegislationEU
- NationalLegislationUS
- NationalLegislationCN

SDScomXML
SECTION 15 (chemical safety assessment)
EuPhraC
SDSComXML
New name of the path?
ChemicalSafetyAssessmentInfo/ChemicalSafetyAssessmentEU
Placeholder for other potential legal area specifics

SDScomXML
SDSComXML scheme
SDScomXML 5.0 –
International Enhancements
Dirk Henckels
Qualisys GmbH
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Overview on regulatory environm

1. SDScomXML 1 Overview on regulatory environment with impact on SDSCom (C) eSDScom Alliance UG, www.esdscom.eu Licensed under CC-BY-SA 4.0: http://creativecommons.org/licenses/by-sa/4.0/

2. SDScomXML Part I: EuPhraC structure correlation to SDSCom

3. SDScomXML The dilemma

4. SDScomXML Challenges 1. National chemical inventories and REACH-like regulations 2. National lists of banned chemicals, restrictions and authorizations 3. National GHS (C&L rules, chemical lists with legal C&L) 4. National SDS templates and specialities (e.g. ext. SDS in EU)

5. SDScomXML Safety Data Sheet (SDS) general topics with relation to legal areas 1. Header and sub-header, e.g. „Safety data Sheet according ….“ „Classification according to …..“ 2. Languages, e.g. „EU-ES (European Spanish)“ „MX-ES (Mexican Spanish)“ 3. Different contents, e.g. „SECTION 1, 2, 8, 11, 12, 13, 14, 15“ (see next slide) 4. Special annexes, e.g. „Exposure scenarios“ in Europe  ESCOM

6. SDScomXML Safety Data Sheet Overview on specific topics with relation to legal areas SECTION 1: product identifier and poison centre information SECTION 2: classification and labelling SECTION 3: hazardous ingredients SECTION 8: workplace and biological threshold limit values SECTION 11: special toxicological information, e.g. IARC (USA) SECTION 12: special ecotoxicological information, e.g. EU SECTION 13: special information such as EU-waste codes catalogue SECTION 14: land transport information such as DOT (USA) SECTION 15: downstream regulations and national inventory status

7. SDScomXML SECTION 1 (EU) EuPhraC SDSComXML (not yet assigned) Are there other legal area specific fields to be implemented? Input via EuPhraC proposal tool.

8. SDScomXML SECTION 2 (EU) EuPhraC SDSComXML Expansion to other SDScom path required such as: - UNClassfication - HCSClassification - AU-GHSClassification

9. SDScomXML SECTION 3 (substances and mixtures) EuPhraC SDSComXML Legal area specific modification required? SubstanceNameEU Expansion to other SDScom path required such as: - SubstanceNameUS - SubstanceNameCN - SubstanceNameCD

10. SDScomXML SECTION 8 EuPhraC SDSComXML

11. SDScomXML SECTION 12 (EU) EuPhraC SDSComXML New name of the path? ResultsOfPbtVpvbAssessmentEU

12. SDScomXML SECTION 15 (national regulations) EuPhraC SDSComXML Better split-off in other legal areas? - NationalLegislationEU - NationalLegislationUS - NationalLegislationCN

13. SDScomXML SECTION 15 (chemical safety assessment) EuPhraC SDSComXML New name of the path? ChemicalSafetyAssessmentInfo/ChemicalSafetyAssessmentEU Placeholder for other potential legal area specifics

14. SDScomXML Part II: Technical solutions

15. SDScomXML SDSComXML scheme SDScomXML 5.0 – International Enhancements Dirk Henckels Qualisys GmbH become curious?

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