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UFI and PCN - providing information to poison centres

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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.

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UFI and PCN - providing information to poison centres

  1. 1. Vid Čopi Ljubljana, 21 November 2018 •1 Providing information to poison centres – UFI and PCN
  2. 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 2
  3. 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 3
  4. 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 4
  5. 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 5 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. 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. 6 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. 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 7 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. 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 8
  9. 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 9
  10. 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 10 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. 11. Examples of entering composition for a PCN file 11
  12. 12. 12
  13. 13. 13 100% composition means only contained substances and mixtures! (no information about the manufacturing process is included)
  14. 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. 14
  15. 15. An example of level-based decision making in the EuPCS system 15 See the article on our blog for a more in-depth explanation of the EuPCS.
  16. 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 16
  17. 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. 17 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. 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 18
  19. 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) 19
  20. 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). 20
  21. 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. 21
  22. 22. FURTHER QUESTIONS? 22

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