We offer SDS editing, UFI number generation and completion of UFI dossiers for Article 45 & Annex VIII of CLP. We submit dossiers through ECHA database for European submissions and prepare Northern Ireland/GB/UK dossiers for onward submission.
Why do products need a UFI number/registration with the Poison Centres? Generating a Unique Formula Identifier (UFI) and ensuring it is visible on the product is an industry obligation. It is now a requirement to provide a dossier of information regarding hazardous products to be submitted to Poison Centres, so that emergency responders can obtain accurate information about the composition of a product.
Candles, wax melts, reed diffusers and other home fragrance products fall under the remit of CLP and therefore these products will require (where required due to the nature of the hazards triggered) a UFI number to be present on the CLP label and the formulation information submitted to the Poison Centre Portal Notification (PCN) via a dossier.
When do home fragrance makers require UFI? EU Member States (including Northern Ireland) – from 1st January 2021, UFI Dossier registration is a requirement if your finished product to marketplace triggers one of more of the below pictograms.
Requirements for completing a UFI Dossier: · A European entity address (please note: Northern Ireland addresses are classed as a European entity address)
· The SDS for the finished product (for example; SDS at 10% in a non-hazardous base for candle/wax melt and SDS at 25% in augeo base for diffuser). The information within this SDS is required to build the dossier.
· A list of EU marketplace countries that you wish to submit to. Most EU submission are free of charge however, Hungary, Italy and Belgium are charging fees for notifications, and Croatia and Spain are taking it into consideration. Hungary: 16,000HK per product / per year Italy: 50€ per company / per year Belgium: 200€ or 35€ per product / one-time fee Bulgaria is not receiving dossiers as yet through the portal
· Section 11 (toxicology) of the final product SDS must be in the accepted notification language of product marketplace. I can provide further information and translation services.
· An ECHA Account (passwords can be changed afterward the work is completed). Link to open ECHA account https://idp.echa.europa.eu/ui/login · Details of the type of packaging
· Details of the product weights
· Trade name/s of your product · PH Balance (diffuser only/liquids only) - I can give further guidance Please note that: · a new dossier will need to be completed for any fragrance oils that have been reformulated or reclassified
· the dossier will need to be updated if the packaging and/or product weights are changed; the range is added to in any way; or the addition of a new marketplace country
· It is not one dossier per fragrance - ECHA splits the home fragrance products into different categories ie candles and wax melts may share the same recipe but they are reported in separate categories and therefore need two dossiers to be submitted. Diffusers are also a separate category.
· I am responsible for the completion of the UFI dossier with the information given to me. I am not responsible for errors incurred should I be given incorrect information. Please note that at this stage, not all fragrance oil suppliers have this documentation available. FOR NORTHERN IRELAND/GB/UK DOSSIER SUBMISSIONS: Great Britain (GB) is no longer within the EU and therefore dossiers cannot be submitted directly through the ECHA database to the UK Poison Centre. Furthermore, GB have not adopted the EU legislation and UFI's are not required. Northern Ireland, in reporting terms is separate from GB and is required to follow European UFI legislation. Therefore, all Northern Ireland/UK/GB dossiers, will be emailed to you in.i6z format. These files cannot be opened on desktop but the can be viewed within your ECHA account. This is the format that is accepted by the UK Poison Centre in England. You will be responsible for the onward submission of the dossiers to the UK Poison Centre (sds.npis@nhs.net). I will guide you through this straight forward process.
FOR EUROPEAN DOSSIER SUBMISSION: I will complete the submission through the ECHA database to the relevant marketplace country.
For more information, please see https://www.gov.uk/guidance/submitting-chemicals-information-to-the-national-poisons-information-service Please contact me for current rates any further queries - I am very happy to assist.
Jacki Urey