In this feature article Caroline Raine discusses the recent developments with regards to the forthcoming legal requirement to notify hazardous mixtures to poison centres. Caroline reminds us of the legal obligations introduced by the new Annex VIII to EC Regulation 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (CLP) and provides an update on the supporting information made available by the European Chemicals Agency (ECHA).
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.
Consumer use — 1 January 2020.
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 1 January 2025 when all existing notifications must be updated to the new requirements.
Poison Centre First deadline to be postponed
The Competent Authorities for REACH and CLP (CARACAL) have agreed unanimously to the European Commission’s proposed changes to Annex VIII to CLP.
This will mean that the first compliance date for harmonised reporting to poison centres, for mixtures intended for consumer use will be postponed from 1 January 2020 to 1 January 2021. Both consumer and professional mixtures will have the same date the 1st January 2021.
The Commission is now proceeding with adopting a delegated act, this may be delayed until early 2020. Another amendment of Annex VIII is expected later on in 2020 to address some of the workability issues.
Poison centres: guidance document
The ECHA has recently updated its guidance document and is in fact working on version 3. The guidance document version 2 was published in July 2019 and is available on the ECHA website.
Poison Centres Notification (PCN) format
June 2018 saw ECHA release the new Poison Centres Notification (PCN) format. The new format can be used to notify hazardous mixtures to Member State appointed bodies. The new format is an XML file that is compatible with IUCLID and provides a harmonised approach for notifications. The file includes product identification, hazard identification, composition, toxicological information and the new label element — the Unique Formula Identifier (UFI).
The PCN can be downloaded from the Poison Centres website. In addition, there are a number of other documents available on the website, including:
PCN Format: the format is available as a set of XML Schema Definition (XSD) files. There is also a data model that shows all relevant fields and their interconnections.
Preparing a PCN Dossier — Part A: this provides a technical background and offers a practical guide to industry on how to encode, prepare and complete a dossier that is compliant with the PCN format.
Developers' Guide to IUCLID Format — Part B: this explains the structure of the IUCLID file so that developers can build other systems than IUCLID 6, which can generate this format.
Examples of PCN files are also provided for both single and group notifications.
Guide for European Product Categorisation System
In July 2018, the ECHA published a new guidance document The European Product Categorisation System: A Practical Guide. The European Product Categorisation System (EuPCS) is used to describe the intended use of a mixture for which a notification needs to be made to a poison centre according to Article 45 and Annex VIII of the CLP Regulation. The document lists the product categories and explains the principles of the EuPCS.
More about the EuPCS can be found on the ECHA website.
New poison centre study
Also in July 2018, the European Commission launched a new study on the workability issues that surround poison centres and the new requirements of Annex VIII of CLP to notify information on hazardous chemical mixtures for emergency health response. The workability study will analyse the provisions of Annex VIII of CLP and look into the concerns raised by several trade associations in the petroleum, construction products and industrial gases sectors.
The study is expected to take a year to complete and interim results will be presented and discussed in the Steering Group and Stakeholder Advisory Group in 2019 as well as to CARACAL.
The workability concerns raised by both CONCAWE (petrochemical association) and CEPE (the voice of paint, printing ink and artists’ colours) have been published on the Poison Centres website.
CONCAWE is suggesting that:
“The limits on concentration range widths in Tables 1, 2 and 3 in Annex 1 shall not apply to petroleum products, provided that a reference to a relevant specification or standard is included in the information submitted according to Section 1.2 of Part C of this Annex.” And has stated that:
“The petroleum industry is ready to provide information on how petroleum products are manufactured and classified.”
While CEPE has stated that:
“Under the current rules group submission will be prevented or restricted for many large colour mixing systems — Casts doubt on validity of the Commission’s 2015 costs/benefits assessment. The large added burden for industry and Poison Centres is not perceived to be outweighed by added value for emergency response or preventive measures. Solutions should be found to enable the benefits of group submission to be leveraged.”
ECHA Submission Portal
The final piece of the puzzle, the Submission Portal was released in April 2019. It has since been updated in October 2019.
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.
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.
Member State Implementation
Each Member State is implementing the new Annex VIII harmonised format for notifications at a different pace. ECHA have produced a document which shows how ready each Member State is, which languages they will receive notifications in and the fees they intend to charge. This document is continuously being updated and can be found on the poison center website.
There is still a lot of work to be done by both the ECHA and the European Commission to ensure that all of the tools are in place to support industry to meet the first deadline of 1 January 2020. 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.
The 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 2020 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.
The 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.