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 Associate Director Poison Centre Poison Centre Poison Centre – Regulatory Manager Consultant Consultant
Agenda Introduction to poison centres Annex VIII to CLP • What is it? • How will it affect businesses? • Harmonised submission portal ECHA Tools Member State Intentions for Annex VIII notifications Why wouldn’t you notify now? Question and answer session
Poison centres
Article 45 of CLP Notifier Appointed body Poison Poison Poison centre centre centre 5
Who does the regulation apply to? In scope Exemptions Mixtures with a health or physical Anything exempt effect from CLP classification Mixtures solely Biocides for research and development Explosives and Detergents and non-hazardous cleaning agents gases
Who must notify? ‘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.’ Member State Global Importer or manufacturer downstream user placing on the EU market supplier providing SDS
CLP Article 45 Member State variation in implementation UK France Spain Poland Full composition Full composition Hazardous SDS UFI Information components SDS Label SDS EAN codes for format Types of packaging Label consumer products Quantity on the market Types of packaging Yes, phased Yes, phased Mandatory Voluntary hazard submission usage submission Yes (Best practice) submission over 8 years over two years Web portal and Submission Email Web portal specialist software to Web portal process generate .xml format Submission €30 for each new Submission free but pre- Free Free registration costly. product fee Official No Yes No Yes advisory body 8
Annex VIII to CLP Commission regulation (EU) 2017/542 of 22 March 2017 Image credit: ECHA
What changes will Annex VIII bring? 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
Timeline Pre 2020 • Notification mandatory in all MS under current requirements • New information requirements for Consumer mixtures 2020 • New information requirements for Professional mixtures 2021 • New information requirements for Industrial mixtures 2024 • Pre-Annex VIII submissions expire 2025
Unique Formula Identifier UFI JY10-Y0JM-W006-8975
100% Composition Ranges Exact or Actual Max width Acute toxicity, category 1, 2 or 3 concentration of range Specific target organ toxicity – single ≥ 25 - < 100 5 % units exposure, category 1 or 2 Specific target organ toxicity – repeated ≥ 10 - < 25 3 % units exposure, category 1 or 2 ≥ 1 - < 10 1 % units Skin corrosion, category 1, 1A, 1B or 1C ≥ 0.1 - < 1 0.3 % units Serious eye damage, category 1 >0 - < 0.1 0.1 % units
Mixture in a Mixture (MIM)
Mixture in a Mixture (MIM) update Change to product that requires update and triggers new UFI Company A Uses company A’s UFI in own notification. Must submit new notification and generate new UFI Company B Uses company B’s Uses company B’s mixture in theirs. Must mixture in theirs. Must submit new notification submit new notification and generate new UFI and generate new UFI Company C Company D
Conclusion Generic product identifiers and group submissions 16
Reduced notification requirements
Numbers to use in section 1.4 of the SDS
cefic level 1 guidelines ✓ 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
What data is required for the notification ?
Checklist of information for notification 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 or other names) ✓ 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)
Checklist of information for notification ✓ 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)
Brexit
ECHA tools UFI EuPCS Notification Guidance document portal Image credit: ECHA
UFI Generator – READY Unique Formula Identifier Generator Source credit: https://ufi.echa.europa.eu/#/create
EuPCS – READY European Product Categorisation System Image credit: https://poisoncentres.echa.europa.eu/documents/22284544/22295820/eupcs_support_manual_en.pdf
Guidance document Image credit: https://www.echa.europa.eu/documents/10162/13643/guidance_on_annex_viii_to_clp_en.pdf
Notification portal Image credit: ECHA REACH-IT portal
Notification portal Image credit: ECHA REACH-IT portal
Notification portal Image credit: ECHA REACH-IT portal
Notification portal Image credit: ECHA REACH-IT portal
Annex VIII – Member State intentions Source credit: https://poisoncentres.echa.europa.eu/documents/22284544/27487986/msd_en.pdf/982d9115-58cb- 75c8-80ae-8eb16f5c0009
Annex VIII – Member State intentions Source credit: https://poisoncentres.echa.europa.eu/documents/22284544/27487986/msd_en.pdf/982d9115-58cb-75c8-80ae-8eb16f5c0009
Submission portal Acceptance via ECHA portal only Via National System or ECHA portal Member States yet to specify
Are they ready yet?
Languages
Fees
Placing on the market
Extension?
Annex VIII to CLP Workability study Image credit: ECHA
Battle plan
How to prepare for Annex VIII notifications? Identify UFI Understand your supply Notification file chain Allocate internal reference codes to all Where are you placing Apply the European applicable products onto the market? product categorisation system Use these to start Are you a duty holder? generating UFIs Prepare your notification Are your products used files by 2019/2020 Get these on your labels in other organisations by 2020/2021 formulations? Monitor the poison centre notification format Notify by the 1 st of Jan 2020/ 2021/ 2024
Benefits of notifying now Less No rush to Free in most Responsible UFIs on labels information - notify in Q3 of Member States care by 2025 fewer updates 2019
Free regulatory health check We are offering a free regulatory check to the first 10 customers who register for one of the following services: 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
Conclusion NCEC Poison centre resources Visit: www.the-ncec.com/poisoncentres Poison centre notifications Poison centre consultancy Poison centre compliance report Sit on the ECHA guidance groups 45
Contact us E: poisoncentres@ricardo.com T: +44 (0)1235 753479 Caroline Raine W: www.the-ncec.com/poisoncentres Associate Director – Regulatory
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