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

Introduction to Article 45 and Annex VIII to the CLP

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  

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.

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).

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 ​

* 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’.

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

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 2025 - unless change made to existing notification in period from relevant deadline to end of transition period.

Understanding the deadlines

Understanding the deadlines

Understanding the deadlines

Harmonisation of information

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

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%.

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

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.

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

Unique fomular identifier (UFI)

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

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.

The UFI rule A single code UFI is assigned to one (and only one) mixture composition UFI: VDU1-414F-1003-1862 UFI: VDU1-414F-1003-1862

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

What you need to generate UFI? VAT number of your company Formulation number UFI Generator tool https://ufi.echa.europa.eu/#/create Support: ’UFI generator application guide’ ’Developer’s manual’ https://poisoncentres.echa.europa.eu/publications

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 https://poisoncentres.echa.europa.eu

EuPCS (European product categorisation system)

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.

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

Current status Version 1.0 available. Practical support manual available. https://poisoncentres.echa.europa.eu/fi/eu-product-categorisation-system

PCN (poison centres notification) format and portal

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

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.

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

Dossier preparation and submission

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.

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.

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.

Steps for the non EU supplier

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.

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.

Need more support? Draft Guidance available now Contact us! https://poisoncentres.echa.europa.eu/guidance https://echa.europa.eu/contact

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