1. European Association of Poisons Centres and Clinical Toxicologists Product Information Versioning & Product ID Number Herbert Desel GIZ-Nord Poisons Centre University Medical Centre Göttingen, Germany Workshop on the Harmonisation of Information for Poisons Centres - CLP Article 45(4) CLP - Regulation on Classification, Labelling and Packaging of Substances and Mixtures Brussels 24 November 2010

2. European Association of Poisons Centres and Clinical Toxicologists Entity ‚Product‘ in Poisons Centre Daily Work Typically, an exposure to a ‚product‘ with poisoning concern is notified to a poisons centre. As part of the consultation only a product name is communicated via telephone line

3. European Association of Poisons Centres and Clinical Toxicologists Ideal Entity ‚Product‘ entity ‚product‘ product name formula Information for PC corrosive

4. European Association of Poisons Centres and Clinical Toxicologists The Ideal Product Information for Poisons Centres The product name can easily be identified on the label There is one single formula of the ‚product‘ –or there is a product identification element on the label One single product information document describes all product formula related data

5. European Association of Poisons Centres and Clinical Toxicologists The Real Product Information for Poisons Centres In worst, but not rare cases: The product name cannot be reliably identified on a busy label Several formulae of the product are on the market There is no product identification element on the label There are several product data documents with identical (or very similar) product names

6. European Association of Poisons Centres and Clinical Toxicologists Entity ‚Product‘ entity ‚product‘ product name formula #1 Information for PC #2Information for PC #1... formula #2... product name #2 irritantcorrosive Only the newest data set is relevant and validfor each formula

7. European Association of Poisons Centres and Clinical Toxicologists Why to Notify Additional Product Information? 1.Change in submitted data but no change in product composition 2.Change in formula without change of product name

8. European Association of Poisons Centres and Clinical Toxicologists 1 Change in Submitted Product Data (without change in product formula - real world examples) To correct spelling errors e.g. from „H I P O Cleaner“ to „HIPO Cleaner“ To update name e.g. change „HIPO Cleaner“ to „HIPO Cleaner classic“ To correct product formula data errors e. g. notification of aluminium sulfate in descaler by error To submit additional data –change in safety information (safety data sheet) –out-of-market date (important for poisons centers)

9. European Association of Poisons Centres and Clinical Toxicologists PC Protocol for Handling of Changes in Submitted Data After notification of data changes –new data have to replace old data –the (correctly identified) old data set has to be deleted (by overwrite procedure) or labelled as invalid (disabled for routine access)

10. European Association of Poisons Centres and Clinical Toxicologists 2 Change in Formula To make product better to make product safer...... but keeping the product name unchanged for practical reasons

11. European Association of Poisons Centres and Clinical Toxicologists Change in Formula (While Not Changing the Name on Label) Notification of changes –new data have to / may be be stored in addition to old data –the old data set need/should not deleted, nor labelled as invalid but may be labelled as ‚old‘ or ‚outdated by a new product formula‘

12. European Association of Poisons Centres and Clinical Toxicologists How to communicate these needs on the technical level? Two Identifiers are needed for correct data processing Product Formula Identifier (PFI)

13. European Association of Poisons Centres and Clinical Toxicologists Product Formula Identifier (PFI) PFI facilitates identification of a specific product formula –on a technical level for controlling data exchange –to recognise whether a new data set may replace an outdated data set: PFI not existing in PC data dase: new product entry PFI already existing in PC data dase: replace old data set

14. European Association of Poisons Centres and Clinical Toxicologists Product Formula Identifier (PFI) and product identification element PFI and product identification element have similar meaning, but on different levels of product identification product identification element on the label will become an important voluntary item for product identification –visible on the label and visible for the PC officer on duty PFI will become a technically important mandatory item of the product data format (and notification procedure) –not visible on the label and for the PC officer There should be a link between them.

15. European Association of Poisons Centres and Clinical Toxicologists Notification of any change in formula leads to a change in Product Formula Identifier (PFI) Important Rule I

16. European Association of Poisons Centres and Clinical Toxicologists How to communicate these needs on the technical level? Two Identifiers are needed for correct data processing Product Formula Identifier (PFI) Data Set Version Identifier (DVI)

17. European Association of Poisons Centres and Clinical Toxicologists Data Set Version Identifier (DVI) The DVI is used to identify the most recent version of a product formula data set (with identical formula and PFI) Temporal hierarchy must be recorded unambiguously –notification of date of notification is important

18. European Association of Poisons Centres and Clinical Toxicologists Important rule II Notification of a change in product data only does not leads to a change in Product Formula Identifier (PFI) but leads to a change in Data Set Version Identifier (DVI) (see Guideline Document)

19. European Association of Poisons Centres and Clinical Toxicologists Conclusion The Product Formula Identifer (PFI) should become a mandatory item of the format –technical recommendation: Universally Unique Identifier ( UUID) Data Set Version Identifier (DVI) should become a mandatory item of the format –Technical recommendation: date-time stamp of notification

20. European Association of Poisons Centres and Clinical Toxicologists entity ‚product‘ product name formula #1 Information for PC #2Information for PC #1... formula #2... product name #2 irritantcorrosive Only the newest data set is relevant and validfor each formula Thank you following me … though the judge of versioning