Clp Article 45 support in SDScom 4.4.0

BDI
BDIBDI
Clp Article 45 support
in SDScom 4.4.0
7th BDI SDScom Workshop, Berlin, 15.05.2019
Dr. Dirk Henckels, Qualisys GmbH
Support of PCN data
A guide
to additional hazmat data requirements
when you rework existing SDSs for future
notification.
What a hassle!
:(
Mapping of IUCLID picklists
Function of a component according to Iuclid6 picklists N28
and N28A (map "stabilizer" to "stabilizer: other"):
2675 absorbent
1699 active substance
2680 adsorbent
2693 anticaking agent
●
For readability and IUCLID independence, enumeration
types contain full text, not IUCLID codes
●
IUCLID codes are maintained in annotations
Function (Section 3)
PCN picklists in SDScom
●
ColourEnum = IUCLID PG6-60569
●
ColourIntensityEnum = IUCLID PG6-60568
●
ComponentFunctionEnum = IUCLID N28 and N28A
●
CompositionTypeEnum: For IUCLID N08, enhanced with „Mixture: Polymer“
●
EuPCSEnum = IUCLID PG6-60567
●
FormEnum = IUCLID A101
●
FormulationTypeEnum = IUCLID B04
●
JustificationForUpdateEnum = IUCLID PG6-60571
●
PackagingMaterialEnum = IUCLID B07
●
PackagingTypeEnum = IUCLID B05
●
SubstanceTypeEnum = IUCLID N58
https://github.com/esdscom/sdscom-xml/commit/3b9f3795d9bc029d73d8d025bd5a3b27bc6715d
https://github.com/esdscom/sdscom-xml/commit/04954f2be1c9e1d046c0ed1dd4598e77d2c14962
UFIs
●
Represented with dashes
●
Multiple UFIs possible:
– To represent multiple products in one SDS
– If the manufacturer assigned multiple UFIs to the same
product (e.g., market specific or packaging specific)
Other changes in 4.4.0
Acronym list
●
Represented as pairs of acronym string and phrase
●
Alternatively, use list of phrases
Integration of EScom, SDScom, SUMI
Previously:
●
SUMI implemented in SDScom
●
ESCom referenced via file name
Now, in addition:
●
Exposure Scenario reference via UUID
in type Substance
Swiss Regulatory Content
Full List of Changes
Thank you!
Dr. Dirk Henckels
+49 2173 39916 114
dirk.henckels@qualisys.eu
1 sur 14

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Clp Article 45 support in SDScom 4.4.0

  • 1. Clp Article 45 support in SDScom 4.4.0 7th BDI SDScom Workshop, Berlin, 15.05.2019 Dr. Dirk Henckels, Qualisys GmbH
  • 3. A guide to additional hazmat data requirements when you rework existing SDSs for future notification.
  • 5. Mapping of IUCLID picklists Function of a component according to Iuclid6 picklists N28 and N28A (map "stabilizer" to "stabilizer: other"): 2675 absorbent 1699 active substance 2680 adsorbent 2693 anticaking agent ● For readability and IUCLID independence, enumeration types contain full text, not IUCLID codes ● IUCLID codes are maintained in annotations
  • 7. PCN picklists in SDScom ● ColourEnum = IUCLID PG6-60569 ● ColourIntensityEnum = IUCLID PG6-60568 ● ComponentFunctionEnum = IUCLID N28 and N28A ● CompositionTypeEnum: For IUCLID N08, enhanced with „Mixture: Polymer“ ● EuPCSEnum = IUCLID PG6-60567 ● FormEnum = IUCLID A101 ● FormulationTypeEnum = IUCLID B04 ● JustificationForUpdateEnum = IUCLID PG6-60571 ● PackagingMaterialEnum = IUCLID B07 ● PackagingTypeEnum = IUCLID B05 ● SubstanceTypeEnum = IUCLID N58 https://github.com/esdscom/sdscom-xml/commit/3b9f3795d9bc029d73d8d025bd5a3b27bc6715d https://github.com/esdscom/sdscom-xml/commit/04954f2be1c9e1d046c0ed1dd4598e77d2c14962
  • 8. UFIs ● Represented with dashes ● Multiple UFIs possible: – To represent multiple products in one SDS – If the manufacturer assigned multiple UFIs to the same product (e.g., market specific or packaging specific)
  • 10. Acronym list ● Represented as pairs of acronym string and phrase ● Alternatively, use list of phrases
  • 11. Integration of EScom, SDScom, SUMI Previously: ● SUMI implemented in SDScom ● ESCom referenced via file name Now, in addition: ● Exposure Scenario reference via UUID in type Substance
  • 13. Full List of Changes
  • 14. Thank you! Dr. Dirk Henckels +49 2173 39916 114 dirk.henckels@qualisys.eu