Poison centres: Annex VIII the new harmonised not quite harmonised - - PowerPoint PPT Presentation
Poison centres: Annex VIII the new harmonised not quite harmonised approach Caroline Raine | Associate Director Regulatory www.the-ncec.com/poisoncentres NCEC Poison centre team Caroline Raine Emma Cunningham Jon Curry Chris Stone
Poison centres: Annex VIII – the new harmonised not quite harmonised approach
Caroline Raine | Associate Director – Regulatory
www.the-ncec.com/poisoncentres
Jon Curry
Poison Centre Consultant
Caroline Raine
Associate Director – Regulatory
Emma Cunningham
Poison Centre Manager
Chris Stone
Poison Centre Consultant
Introduction to poison centres
Annex VIII to CLP ECHA Tools Member State Intentions for Annex VIII notifications Why wouldn’t you notify now? Question and answer session
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Mixtures with a health or physical effect classification Biocides Detergents and cleaning agents
Anything exempt from CLP Mixtures solely for research and development Explosives and non-hazardous gases
Member State Importer or downstream user placing on the market
‘Placing on the market’ according to Article 2(18) of CLP ‘means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.’ Global manufacturer EU supplier providing SDS
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UK France Spain Poland Information format
SDS Full composition SDS Label Types of packaging Quantity on the market Full composition UFI SDS Label Types of packaging Hazardous components EAN codes for consumer products
Mandatory submission
Voluntary (Best practice) Yes, phased hazard submission
Yes, phased usage submission
Yes
Submission process
Email Web portal Web portal and specialist software to generate .xml format Web portal
Submission fee
Free Submission free but pre- registration costly. €30 for each new product Free
Official advisory body
No Yes No Yes
Image credit: ECHA
Unique formula identifiers (UFI) Declaration of full composition for consumer and professional goods Standardised procedure for mixtures in mixture submissions Reduced submission for industrial mixtures Group submissions and generic product identifiers European product categorisation system EU common format for submissions
Pre 2020 • Notification mandatory in all MS under current requirements 2020
2021
2024
2025
UFI JY10-Y0JM-W006-8975
Exact Ranges
Actual concentration Max width
≥ 25 - < 100 5 % units ≥ 10 - < 25 3 % units ≥ 1 - < 10 1 % units ≥ 0.1 - < 1 0.3 % units >0 - < 0.1 0.1 % units
Acute toxicity, category 1, 2 or 3 Specific target organ toxicity – single exposure, category 1 or 2 Specific target organ toxicity – repeated exposure, category 1 or 2 Skin corrosion, category 1, 1A, 1B or 1C Serious eye damage, category 1
Change to product that requires update and triggers new UFI Company A Uses company A’s UFI in
submit new notification and generate new UFI Company B Uses company B’s mixture in theirs. Must submit new notification and generate new UFI Company C Uses company B’s mixture in theirs. Must submit new notification and generate new UFI Company D
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✓
Available at all times
✓
In the local language
✓
Connection in 3-5 minutes
✓
Access to expert network
✓
Knowledge of chemicals and chemical behaviour
✓
Advice tailored to the circumstances
✓
Tactical awareness
✓
Regulatory awareness
The information that needs to be submitted is set out in Part B of Annex VIII and includes; ✓ Identification of the mixture and the submitter ✓ Product identifier of the mixture – the trade name or names (including the brand name
✓ The unique formula identifier (UFI) of the mixture ✓ The name, address, phone number and email address of the submitter ✓ Hazards identification and additional information ✓ Classification of the mixture (hazard class and category) ✓ Label elements ✓ Hazard pictogram codes ✓ Signal word ✓ Hazard statement codes, including supplemental hazard information codes ✓ Precautionary statement codes ✓ Toxicological information ✓ Description of the toxicity of the mixture or its components (as required in Section 11 of the Safety Data Sheet)
✓ Additional information ✓ Colour ✓ pH (where applicable) ✓ Physical state ✓ Packaging (type and size) ✓ Intended use (product categorisation code) ✓ Uses (consumer, professional, industrial) ✓ Product identifiers of the mixture components ✓ Chemical/trade name of the components ✓ CAS number (where applicable) ✓ EC number (where applicable) ✓ Exact concentration or concentration ranges of the mixture components ✓ Classification of mixture components (substances and MIM) ✓ Hazard classification of each component (where applicable) ✓ Additional identifiers (where applicable and relevant for health response)
UFI EuPCS Notification portal Guidance document
Image credit: ECHA
Source credit: https://ufi.echa.europa.eu/#/create
Unique Formula Identifier Generator
European Product Categorisation System
Image credit: https://poisoncentres.echa.europa.eu/documents/22284544/22295820/eupcs_support_manual_en.pdf
Image credit: https://www.echa.europa.eu/documents/10162/13643/guidance_on_annex_viii_to_clp_en.pdf
Image credit: ECHA REACH-IT portal
Image credit: ECHA REACH-IT portal
Image credit: ECHA REACH-IT portal
Image credit: ECHA REACH-IT portal
Source credit: https://poisoncentres.echa.europa.eu/documents/22284544/27487986/msd_en.pdf/982d9115-58cb- 75c8-80ae-8eb16f5c0009
Source credit: https://poisoncentres.echa.europa.eu/documents/22284544/27487986/msd_en.pdf/982d9115-58cb-75c8-80ae-8eb16f5c0009
Acceptance via ECHA portal only Via National System or ECHA portal Member States yet to specify
Image credit: ECHA
Identify
Understand your supply chain Where are you placing
Are you a duty holder? Are your products used in other organisations formulations?
UFI
Allocate internal reference codes to all applicable products Use these to start generating UFIs Get these on your labels by 2020/2021
Notification file
Apply the European product categorisation system Prepare your notification files by 2019/2020 Monitor the poison centre notification format Notify by the 1st of Jan 2020/ 2021/ 2024
Free in most Member States Less information - fewer updates Responsible care UFIs on labels by 2025 No rush to notify in Q3 of 2019
Free substance inventory check against ECHA lists Free safety data sheet (SDS) check Free REACH registration dossier check
Request your free regulatory health check today: https://the-ncec.com/regulatory- compliance/free-regulatory-health-check
We are offering a free regulatory check to the first 10 customers who register for one of the following services:
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Poison centre notifications Poison centre consultancy Poison centre compliance report Sit on the ECHA guidance groups
E: poisoncentres@ricardo.com T: +44 (0)1235 753479 W: www.the-ncec.com/poisoncentres
Caroline Raine Associate Director – Regulatory