Rocky Rowe & Stephanie Nadzialek EAN Meeting September 20 th 2018

1. Rocky Rowe & Stephanie Nadzialek EAN Meeting September 20th 2018 Poison Centres New mandatory notification requirements from 2020

2. Poison Centres Notifications – PCN From 2020 hazardous mixtures (includes PPP and BP) must be formally notified to the designated Appointed Body for Poison Centres in each Member State, before placing on the market.

3. Poison Centres Notifications – PCN Background • Article 45 of CLP 1272/2008 mandated the Commission to introduce a system of notification whereby harmonised information can be supplied to Poison Centres. • Work between Commission, Poison Centres, EAPCCT* & Industry lead to an implementing Regulation 2017/542 • The new procedure comes into force January 1st 2020 with consumer products * European Association of Poison Centres and Clinical Toxicologists

4. Poison Centres Notifications – PCN

5. Poison Centres Notifications – PCN Specific Timings New mixtures being placed on the market need to comply with the following:- • Jan 1st 2020 – new consumer products need to be notified. E.g. soaps, detergents, paints, glues including PPP garden products and some biocides. • Jan 1st 2021 – any new professional product including a typical hazardous PPP and biocide. • Jan 1st 2024 – any new industrial mixtures

6. Poison Centres Notifications – PCN Existing Mixtures • Where a mixture has been notified to a national poison centre, most usually by submission of an SDS, then no new notification will be necessary until after January 1st 2025.

7. Poison Centres Notifications – PCN How are notification going to be made? • Two routes for notification are proposed • To individual national appointed bodies • Via an ECHA portal that will check your notification and dispatch it to the designated national appointed bodies. • This route will translate your notification into the appropriate national languages. • ECHA is currently working on validation rules for notifications.

8. Poison Centres Notifications – PCN How will a notification be made ? • ECHA, Poison Centre and Industry IT experts are currently finalizing the IT side however a Standardized XML Format will be used. • This PCN format can be used with either the ECHA Portal or direct with a Member State • The PCN format aims to harmonise and ensure consistency of the information available to poison centres.

9. Poison Centres Notifications – PCN What information do I need to submit ? • Part B of Regulation 2017/542 sets out the information require and includes:- • Identification on the mixture and submitter. • Includes a product identifier, details of submitter, plus the UFI (unique Formulation Identifier) • Classification and labelling elements • Toxicological information • Packaging information • Product Categorisation • Mixture composition

10. Poison Centres Notifications – PCN What do I need to submit? • Unique Formulation Identifier UFI • New concept designed to help poison centres identify a mixture. • The UFI will be printed in a prominent place on the label. • It is a 16 digit number and is assigned by ECHA. https://ufi.echa.europa.eu/#/create • Multiple UFIs can be assigned to one mixture to allow market segmentation. • ECHA Guidance https://poisoncentres.echa.europa.eu/ufi-generator

11. Poison Centres Notifications – PCN What do I need to submit? • Product Categorisation • This describes the main intended use of the mixture • PPP are designated PP-PRD • Biocides are base on use categories and designated PP-BIO • ECHA Guidance on use of the system is available • https://poisoncentres.echa.europa.eu/eu-product-categorisation-system

12. Poison Centres Notifications – PCN

13. Poison Centres Notifications – PCN What do I need to submit? • Mixture Composition • The composition of mixtures now needs to be disclosed more fully than on an SDS. • Industry has resisted the demand for full disclosure and has agreed a banding system based on the individual properties of components. • ECHA Guidance is provided on use.

14. Poison Centres Notifications – PCN

15. Poison Centres Notifications – PCN

16. Poison Centres Notifications – PCN Updating Notifications • Whenever a change in the mixture is made an update will need to made to the system • This could include a change in composition, hazard classification or intended use. • A change as above will also require a new UFI to ensure identification is linked to the revised mixture.

17. Poison Centres Notifications – PCN Industry Concerns • Confidentiality • Whilst confidentiality is cited in Article 45 of CLP the onus is on the appointed bodies to manage this. • Fees • Some Member States have indicated they will be charging for each notification. • Requests for further information • Some Appointed bodies may request further information but only what is reasonable. • Enforcement – how and by whom

18. Poison Centres Notifications – PCN Are you Prepared ? • There is only 16 months to go • Are you familiar with your national appointed body? • Will they be reliant on the ECHA portal for notification or demand national notification? • Will a fee be charged ? • Are you working with your chemical industry colleagues ?

19. Poison Centres Notifications – PCN Are you Prepared? • CLEG would appreciate your feedback on how the notification process will work in your country. • CLEG ready to help an assist where we can. • ECHA web site and guidance documents are a good resource. • https://poisoncentres.echa.europa.eu/home

20. Thank You