1. Notifications for poison centres according to Annex VIII CLP
Chemicals Management Forum
01 October 2018
Belgrade, Serbia
Heidi Rasikari
Poison Centres Team
Dossier Submission Unit
European Chemicals Agency

2. Introduction to Article 45 and Annex VIII to the CLP

3. Article 45(1) of CLP Regulation
Member States shall appoint a body … responsible for receiving information … for formulating preventative and curative measures … in the event of emergency health response, from importers and downstream users placing mixtures on the market. This information shall include the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects…
Who What Why How
​How

4. As a result…
Variation in national notification systems, data format, information requirements.
Difficulties for duty holders to comply from one Member State to another.
Inconsistencies in information available to medical personnel/poison centres in different Member States.

5. Annex VIII to the CLP Published in March 2017.
Harmonisation of information relating to an emergency health response.
->How? Harmonised submission format, containing harmonised information requirements in the official language(s) of the Member State(s) where the mixture is placed on the market (unless they allow otherwise).

6. Mixtures in scope Classified for human health or ​ physical effects ​
Does NOT include:​
Substances​
Mixtures not covered by CLP ​
Mixtures classified only for environmental
effects​
Mixtures used for R&D; PPORDs​
Gases under pressure​
Explosives ​

7. * Who has to submit to appointed bodies?
*Distributors are not considered duty holders - discussions continuing in CARACAL about the role of distributors ‘placing on the market’.

8. ECHA’s obligation under Annex VIII
ECHA also has a foreseen role
…to ‘provide technical and scientific guidance,
technical support, and tools facilitating the
submission of information.’
…free of charge.
Note that it is at the discretion of Member States whether to charge fees

9. Step-wise application dates
For ‘new’ mixtures not already notified – notification always before you place on the market!
Different deadlines dependent on the use type:
1 January 2020: consumer use
1 January 2021: professional use
1 January 2024: industrial use
Before these dates, mixtures continue to be subject to existing national requirements
For ‘existing products’ already notified there is a transition period until 1 January unless change made to existing notification in period from relevant deadline to end of transition period.

10. Understanding the deadlines

11. Understanding the deadlines

12. Understanding the deadlines

13. Harmonisation of information

14. Harmonised information requirements
Submitter details must be consistant with the details on the label.

15. Harmonised information requirements
Full composition to be declared.
Classified for physical or health effects:
Concentrations >=0.1%
Concentrations <0.1% unless ‘irrelevant’.
Not classified for physical or health effects:
Concentrations >=1%.

16. Harmonised information requirements
New elements included:
unique formular identifier (UFI)
Product category according to the new harmonised European product categorisation system (EuPCS).

17. Harmonised information requirements
Harmonised PCN submission format is IUCLID (xml) compatible. Notifiers can benefit from the internationally recognised IUCLID platform, e.g.
IUCLID tool for the validation of data before submission.
Full compatability with the ECHA cloud services for data hosting.

18. Information must be kept up to date!
If there is:
Change in mixture product identifier (incl. UFI), or
Change in mixture classification for health or physical hazards, or
Relevant new toxicological data becomes available, or
Significant changes in composition
THEN:
Submit update before placing mixture as changed on the market

19. Unique fomular identifier (UFI)

20. What is the UFI? 16 character code New requirement for industry
Unambiguously identify a product
Included on the label AND
in the notification

21. How does the UFI work?
UFI works to link a specific product on the market to the submitted mixture information.
UFI read from the label of a product in an emergency to poison centre operator.
With other information, e.g. the trade name, rapidly identify the exact product involved in an incident.
Not possible to decode information about the mixture composition -> protects your confidential business information.

22. The UFI rule
A single code UFI is assigned to one (and only one) mixture composition
UFI: VDU1-414F
UFI: VDU1-414F

23. Using the UFI for mixtures/products
One mixture composition may have multiple UFIs assigned to it

24. What you need to generate UFI?
VAT number of your company
Formulation number
UFI Generator tool
Support:
’UFI generator application guide’
’Developer’s manual’

25. More information on UFI available
UFI animation
What is the UFI?
UFI in brief
UFI – what it means for your
product labels
UFI webinar
UFI for your mixtures and
products

26. EuPCS (European product categorisation system)

27. EuPCS – purpose
New industry requirement under Annex VIII to categorise mixtures according to the intended use, e.g. an adhesive or detergent, detailed in the harmonised EuPCS.
Support appointed bodies at EU level for reporting of poisoning incidents – ensure comparable statistics among MS.

28. EuPCS –principles Categories are based on intended use
Dual use products reflect the main intended use
Hierachical structure with 5 levels and 250 categories including definitions
Coding system for each level

29. Current status Version 1.0 available.
Practical support manual available.

30. PCN (poison centres notification) format and portal

31. PCN format Harmonised submission format
Version 1 published in April 2018
set of XML schema definition files (XSDs)
compatible with IUCLID 6
data model showing all relevant fields and interconnections
Pilot on-going to validate the format
Version 1.1 by end of 2018

32. Understanding the PCN format
Part A – Preparing a PCN dossier
XML content and the inner structure of the PCN format is explained in a simple manner.
Part B – Developer’s Guide to IUCLID format
The structure of the IUCLID 6 file is explained in order for developers to build other systems which can generate this format.

33. PCN portal
Central submission system hosted by ECHA in addition to national submission systems.
Gradual implementation of new features e.g. multimarket and multilingual support.
Used by both industry and appointed bodies.
Version 1 early 2019.
Version 2 Nov. 2019

34. Dossier preparation and submission

35. Ways to prepare and submit 1/3
Prepare dossiers online in the PCN portal:
Guided dossier preparation with step by step instructions.
User friendly interface for manual entering of data.
Can submit directly in the portal.
ECHA cloud service available to store dossier.
Dossier validated before submission.
Support SMEs.

36. Ways to prepare and submit 2/3
Prepare dossiers offline using IUCLID:
A specific PCN user interface made available in IUCLID 6.
More advanced option for companies familiar with IUCLID.
IUCLID dossier can be uploaded to the portal or through national submission systems.
Dossier validated before submission.

37. Ways to prepare and submit 3/3
System-to-system integration:
Most advanced dossier preparation and
submission method.
Companies can directly prepare dossier in IUCLID format in their own systems
Submission through automatic transfer to the PCN portal.
Supports companies with large portfolios.
Validations only possible after submission.

38. Steps for the non EU supplier

39. Steps for the non EU supplier
Step 1. Know your portfolio and identify mixtures which would
require notification by your customer.
Step 2. Communicate with your EU importer and understand the use
type in the supply chain and their deadline for your mixture.
Step 3. Determine if you have any Confidential Business Information
concerns.
If no – familiarise yourself with the required information and be
prepared to make it available. Remember more
information than what is in the SDS is required.
If yes – be prepared to make a ’voluntary’ submission
(next slide).
Step 4. Keep information up to date and inform your customer of
any changes.

40. Voluntary submission by non duty holders for protection of CBI
! The UFI (and all other information) must be notified so that poison centres can make the correct link between the product and the relevant information in the event of an emergency.

41. Need more support? Draft Guidance available now Contact us!

42. Thank you! poisoncentres@echa.europa.eu
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