Poison centres: why notify now? – a Brexit special Caroline Raine | Principal regulatory consultant www.the-ncec/poisoncentres
Agenda Introduction to poison centres Annex VIII to CLP • What is it? • How will it affect businesses? • Harmonized submission portal Notifications in 2019 Brexit 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 4
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? Global Manufacturer EU Supplier providing SDS Member State Importer or downstream user placing on the market
CLP Article 45 Member State variation in implementation UK France Spain Poland Full composition Full composition Hazardous SDS UFI components Information format SDS Label SDS EAN codes for Types of packaging Label consumer products Quantity on the market Types of packaging Yes, phased usage Mandatory Voluntary Yes, phased hazard submission over 2 Yes submission (Best practice) submission over 8 years years Web portal and Submission Email Web portal specialist software to Web portal process generate .xml format €30 for each new Submission free but pre- Submission fee Free Free registration costly. product Official Advisory No Yes No Yes 7 Body
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 of Acute toxicity, category 1, 2 or 3 concentration range Specific target organ toxicity – single ≥ 25 - < 100 5 % units exposure, category 1 or 2 Specific target organ toxicity – ≥ 10 - < 25 3 % units repeated 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 15
Reduced notification requirements
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
Brexit
ECHA tools UFI EuPCS Guidance Notification portal document 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 The portal is now live. What do we know so far? How will this impact those who have waited to do their notifications?
Annex VIII – Member State Intentions https://poisoncentres.echa.europa.eu/documents/22284544/27487986/msd_en.pdf/9 82d9115-58cb-75c8-80ae-8eb16f5c0009?
Submission Portal Acceptance via ECHA portal only Via National System or ECHA Portal TBC
Languages
Fees
How to prepare for annex VIII notifications? Identify UFI Understand your supply chain Notification file Allocate internal reference Where are you placing codes to all applicable onto the market? Apply the European products Are you a duty holder? product categorisation Use these to start system Are your products used in generating UFIs other organisations Prepare your notification Get these on your labels formulations? files by 2019/2020 by 2020/2021 Monitor the poison centre notification format Notify by the 1 st of Jan 2020/ 2021/ 2024
Timeline • Member States planning to connect to the portal April – Dec 2019 • Member States from 1 st Jan 2020 1 st Jan 2020 • Legislation change needed TBC? • Still to let us know TBC?
Are they ready yet?
2020 deadline
Enforcement Safety Data Sheets Site audits REACH Annex II Medical emergencies Image credit: ECHA
Safety Data Sheets; REACH Annex II Poison centre numbers must be included in section 1.4 of the SDS if they are an ‘Official Advisory Body’. Mixtures often have to be notified in order to use the numbers. For some member states, substances also have to be notified.
Enforcement – medical emergencies Your products OR Your customer’s formulations
Benefits of notifying in 2019 Less No rush to Free in most Responsible UFIs on labels information- notify in Q3 of Member States care by 2025 fewer updates 2019
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 37
Contact us E: poisoncentres@ricardo.com T: +44 (0)1235 753479 W: www.the-ncec.com/poisoncentres Caroline Raine Principal regulatory consultant
Recommend
More recommend
