Here is the presentation I held at the BENS event on 21st of November 2018 regarding the upcoming changes to providing information to poison centres.

1. Vid Čopi
Ljubljana, 21 November 2018
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Providing information to
poison centres – UFI and
PCN

2. Notifying hazardous chemicals –
Slovenia
• Before import or
placement on the
market
• Basic data about
the hazardous
chemical
• Hazardous
ingredients
• Category /
classification of
use
• Valid safety data
sheet in Slovene
language
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3. Why do we notify hazardous
chemicals?
• Review of the import and manufacture of hazardous chemicals in
Slovenia
• Annual reporting of quantities of the most hazardous categories of
chemicals
• Availability of transparent, well-formatted data about hazardous
chemicals in case of poisoning
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4. Data transparency is very important!
Slovenia:
• Chemical notification in the ISK
• Data is in a structured form
• Key information is quickly
accessible
• If entered information does not
suffice, the safety data sheet is
immediately available
Romania:
• A safety data sheet is sent to the
main poison centre's e-mail
address
• The SDS must be reviewed for
further information
• A SDS is not necessarily
searchable
• Quick and effective response is
not ensured
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5. The purpose of UFI and PCN
• Unifying both, the method of providing information, as well as the
information that is provided to poison centres in EEA member
countries
• Increased transparency and accuracy of the data on hazardous
chemicals that are available to poison centres
• Faster and better response in case of poisoning
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Of course, all of this is achieved by placing more obligations regarding
labelling of products and providing information about chemical mixtures
to the manufacturers and importers.

6. Glossary
• UFI – Unique Formula Identifier
• A 16-character alphanumeric code that must be named on
the label of every hazardous mixture (or on SDS, if it is used
for industrial purposes), placed on the market in the EEA.
• PCN – Poison Centre Notification
• Notification procedure used in every EEA member country
to notify a hazardous mixture. A specific mixture
formulation is assigned to a specific UFI. When a chemical
mixture is notified, the UFI(s) used can then only be used to
notify other mixtures with the exact same formulation.
• PCN file
• A file prepared with the software tool provided by ECHA.
The file is delivered into the poison centre database in the
process of PCN notification.
• Duty holder
• A company that has legal obligations to manage UFI codes
and PCN notifications.
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UFI Formulation
PCN file for a
product
After the submission of
the PCN file, this specific
UFI can only be used for
mixtures with the exact
same formulation

7. Who is a duty holder with PCN / UFI
obligations, what do they affect and
when are the deadlines?
What:
• Mixtures (not substances) classified with health hazards (H3XX)
Who:
• Duty holders:
• Manufacturers of hazardous mixtures
• Importers (from third countries) of hazardous mixtures
• Not duty holders, but still affected by PCN / UFI:
• Companies that change the packaging/name of hazardous mixtures
• Distributors of hazardous mixtures
When:
• For consumer products – from 1st
January 2020
• For professional use products – from 1st
January 2021
• For industrial use products – from 1st
January 2024
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Exception:
Mixtures, notified according to
the national system (e.g. ISK)
before the deadline can be
placed on the market without a
UFI and PCN until 1st
January 2025 or until
formulation change!

8. Generating and using a UFI
• ECHA has published an online
tool
• UFI is generated using a
company’s VAT number
• One formulation number – one
UFI
• The same UFI may not be used
for two different formulations
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9. PCN file
Content (mostly data from SDS):
• Member state for the notification
• Product category
• Information about the submitting
company
• Trade name(s) of the product
• Types of packaging
• Attached SDS
• UFI(s)
• Physical properties
• Toxicological data
• Categorisation and labelling of product
• 100% composition
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10. 100% composition
• List all ingredients, including non-
hazardous ones
• Substance name, CAS/EC,
classification
• Submit the concentration range
• Concentration range width
depends on the classification of
the substance
• Formulation with another mixture
– list the mixture's UFI
• Colourants/perfumes can be
listed as generic components
(without identifiers)
• Certain other exceptions
Actual concentration [%] Maximum permitted
concentration range
width[%]
≥ 25 - < 100 20
≥ 10 - < 25 10
≥ 1 - < 10 3
> 0 - <1 1
Other classifications and non-hazardous chemicals
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Actual concentration
[%]
Maximum permitted
concentration range
width [%]
≥ 25 - < 100 5
≥ 10 - < 25 3
≥ 1 - < 10 1
≥ 0.1 - < 1 0.3
> 0 - < 0.1 0.1
H318, H314, H314.1a, H314.1b, H314.1c, H300.1, H300.2 H301,
H302, H310.1, H310.2, H311, H312, H330.1, H330.2, H331 and
H332

11. Examples of entering composition for
a PCN file
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12. 12

13. 13
100% composition means only
contained substances and
mixtures!
(no information about the
manufacturing process is included)

14. EuPCS – European Product
Categorisation System
• A new system for categorizing chemical mixtures
• Obligatory for PCN notification
• Level-based approach for determining the purpose and use of a
mixture
• In ISK, the tariff code, NACE classification and chemical category
provide similar information.
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15. An example of level-based decision
making in the EuPCS system
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See the article on our blog for a more in-depth explanation of
the EuPCS.

16. Obligations of duty holders
Mixture manufacturer:
• UFI generation
• PCN notification for all countries where the mixture is placed on the
market. This must be done in communication with distributors – the
distributor is not a duty holder!
• Updating PCN notifications in case of changes
• If a formulation of a mixture changes so that the ingredients are outside
the reported concentration areas, a new UFI must be assigned to the
mixture
• Report any changes in the composition down the supply chain
Mixture importer:
• the same as manufacturers
• Acquire data about 100% composition from the supplier from a third
country in accordance with the requirements for the PCN notification
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17. Other participants in the supply chain
Companies that change the packaging/name of hazardous mixtures:
• Report the data about the new name/packaging to the manufacturer
so that the data can be included in the PCN notification at update
• Alternatively: perform the PCN notification independently and refer
to the original mixture’s UFI at composition. Generate your own UFI or
use the UFI of the original mixture (since the formulation is the same).
Distributor:
• Check with the manufacturer if the PCN notification has been made
for all countries where you are placing the mixture on the market.
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IMPORTANT: Distributors and renaming/repackaging companies can
generate their own UFI codes and make PCN notifications, if their
suppliers are unwilling to cooperate with them. In that case they are
responsible for generating valid codes and keeping the notifications
up to date.

18. Submission of a PCN file – PCN
notification
• The PCN file for a chemical mixture must be submitted before
placing the hazardous mixture on the market in the Member State.
• Submission via ECHA portal
• Member States can decide to use their own system for submitting
PCN files simultaneously with (or instead of) the ECHA portal
• Free of charge, but a Member State may decide to charge an
administrative fee for the notification
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19. Expected issues
• Communication with mixture manufacturers regarding their
notification obligations (especially for distributors)
• Communication with suppliers from third countries with regard to
100% composition
• Communication with mixture formulators for industrial and
professional use with regard to composition (until 2021 or 2024)
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20. Unexplained questions
• The PCN file submission system is not yet available and we don't
know how it works
• Will the PCN notification have to be submitted for every Member
State separately?
• UFI and fuels (constant formulation modification)
• How to acquire data about composition from mixture formulators for
industrial and professional use (UFI and PCN obligations take effect
for industrial/professional use mixtures later than for consumer use
mixtures).
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21. Further activities
• Companies that change the packaging/name of hazardous
mixtures:
• Prepare a strategy with regard to UFI and PCN (communication with
suppliers or own registration)
• Distributors
• Check with your suppliers, if they are aware of their obligations with regard
to UFI and PCN
• Manufacturers and importers
• Make a list of formulations that are being placed on the market by you our
your distributors, in which countries and for what types of use (consumer,
professional or industrial use).
• Consider the system that you will use for managing PCN notifications and UFI
codes.
• Prepare for labelling your hazardous mixtures with UFI codes.
• Importers: Explain to your suppliers the requirements that you must fulfil for
placing their mixtures on the market and come to an agreement regarding
the composition information requirement.
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22. FURTHER QUESTIONS?
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