In this feature article, Caroline Raine discusses some of the recent developments surrounding the requirements to notify mixtures to poison centres. Caroline looks at some of the recent tools, the possible deadline extension and Member State implementation.
The regulation concerning CLP (EC Regulation 1272/2008) was amended on 22 March 2017 when EU Commission Regulation 2017/542 was published. This long-anticipated piece of legislation added a new Annex (Annex VIII) to CLP on harmonised information relating to the provision of information for emergency health response.
Those placing hazardous mixtures with health and physical classifications on the market must notify specific information to the Member State poison centres. The requirement to make notifications to appointed bodies and/or poison centres is for mixtures only. The information provided to the ECHA under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is sufficient for substances.
This requirement to notify information on hazardous mixtures has existed for many years now, but up until Annex VIII was introduced each country had implemented its own requirements. The type of information and the format of the information vary from Member State to Member State. Annex VIII introduces a new harmonised format for notifications.
The deadline for industry to make notifications in the new harmonised format to the appointed body depends on the mixture use and as such there is a phased timeline for notification.
In January 2020 COMMISSION DELEGATED REGULATION (EU) 2020/11 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response, was published. This amendment formally delayed the first deadline for consumer mixtures by a year, bringing it in line with the deadline for professional use mixtures. The dates are now;
Consumer and Professional use — 1 January 2021.
Industrial use — 1 January 2024.
For those who have already made notifications in accordance with Article 45(1) before the dates listed above, there is an extended deadline of the 1 January 2025 by which all existing notifications must be updated to the new requirements.
The amendment also allows for the Unique Formula Identifier (UFI) to be added to either the mixture label or the mixture packaging.
Poison centres: guidance document
In July 2019, the European Chemicals Agency (ECHA) published updated Guidance on harmonised information relating to emergency health response. Version 2 of the Guidance on harmonised information relating to emergency health response — Annex VIII to CLP can be found on the ECHA website.
Further guidance and clarification on the obligations of duty holders related to distribution steps has been added. The document now clarifies that the dutyholder could potentially be every operator placing certain mixtures on the market.
Unique Formula Identifier
Annex VII of CLP introduces a new requirement for a Unique Formula Identifier (UFI), which is added to the mixture label. It is a 16-digit code that is made from a company’s VAT number and a unique formulation code (internal number). Companies can choose to have a different UFI for different Member State markets, or different customers. The minimum requirement is for each mixture to have a different UFI.
The Unique Formula Identifier (UFI) can be decoded. The UFI decoder will allow anyone to see the company VAT number which has been used, along with the product code. This may give problems for companies who want to sell the same mixture under different names; or companies who may be using toll manufacturers or reselling products, and they want to keep the company making the mixture private.
The UFI decoder can be found here.
European Product Categorisation System
The European product categorisation system (EuPCS) is used to describe “the intended use of a mixture”. The list of approved uses is maintained by ECHA and is available on their website.
ECHA Submission Portal
The final piece of the puzzle, the Submission Portal was released in April 2019. The portal was then updated in July 2019 it “includes a number of improvements to the tool for online dossier preparation and submission. The most notable of these is the ‘submit online’ functionality, where the user can create a dossier and proceed to the submission page directly without the need to export the dossier first. Other areas of improvement have been made to sections for reporting components and product information”.
The portal was updated again in October 2019 and January 2020 and will continue to have regular updates.
The portal is a secure, online way to centrally manage notifications for hazardous mixtures and is available for use by industry and Member States’ appointed bodies.
Industry can use the portal to prepare, create and submit dossiers and track notifications to the Member States’ appointed bodies.
Member State Implementation
While the preparation of dossiers is fully harmonised based on PCN format, the process of submission is subject to implementation at the level of each Member State.
The ECHA submission portal facilitates the submission process, however further modalities such as fees, acceptance criteria and acceptance timelines are at the discretion of each Member State. This document summarises each Member States intention.
The summary of Member State intentions shows quite clearly that there are only a handful of countries that are ready to receive notifications in the new format. It also shows that many countries are planning to only accept notifications in the language of that Member State. Which will make the toxicological information challenging for notifiers as this is entered in a free text field which then must be translated.
There is still a lot of work to be done by both ECHA and the European Commission to ensure that all of the tools are in place to support industry. Time is tight and companies should start planning now in order to meet the deadline.
As well as making notifications to poison centres, Annex VIII requires labels to have a UFI on the labels of hazardous mixtures.
The UFI is an alphanumeric 16-character code that is generated from the company’s VAT number and an internal code that has been allocated to the product. There are provisions in place if a supplier is not registered for VAT and there is no VAT number. This code must then be placed on the product label and becomes part of the notification to the poison centre.
ECHA has produced a tool for the creation of UFIs, although companies can use their own tool.
This new label element must appear on product labels by 2021 for consumer products, unless the information has already been provided to the poison centre in advance of the new deadline, in which case it will be required by 2025.
The UFI will be mandatory on the label of all products classified for health and physical hazards by 2025.
ECHA held a webinar in April 2018 focusing specifically on what the UFI is and how it can be used. The webinar also covered the tools and support available and gave practical examples. It is worth watching it for further guidance. The recording and copies of the presentations are now available on the ECHA website.
Given that industry is still waiting for many of the tools to become available and the fact that time is so tight, it is seriously worth considering making notifications now to take advantage of the later transition date of January 2025.