Overview on regulatory environm

BDI
BDIBDI
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
The dilemma
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 8
EuPhraC SDSComXML
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
Part II:
Technical solutions
SDScomXML
SDSComXML scheme
SDScomXML 5.0 –
International Enhancements
Dirk Henckels
Qualisys GmbH
become curious?
1 sur 15

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