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Päivi Jokiniemi and Paul Trouth
Article related to: clp
The future for hazardous mixtures in the EU
An upcoming poison centres notification portal will offer an easy-to-use and secure way for industry to prepare and submit information, in a recently released harmonised format, to appointed bodies in different Member States. Here’s what you need to know to start preparing.
Most citizens don’t think much about what the household bottles they keep under their kitchen sinks contain. They usually have shiny labels with phrases like Deep clean!, Ultra power! or Advanced cleaning!
But if you are an importer or downstream user of mixtures, you know that behind these colourful descriptions, there are some rather potent chemicals hiding. They are efficient at cleaning or for other purposes, but they may also be misused and cause a poisoning incident.
If citizens are accidentally poisoned with hazardous mixtures, such as household chemicals, detergents or paints, they can call a national poison centre for emergency health advice.
The poison centres in the EU receive more than 600 000 calls a year. About half of those incidents involve children and in more than 40 % of cases identifying the product is difficult.
Making it easier to identify the product
The main reason for the challenges in identifying the product involved in a poisoning incident is that the trade name is not always clear. This means that even if you are standing with the bottle in your hand while on the phone, identifying it for those on the other end of the line may not be straightforward.
A new label element called the unique formula identifier (UFI) links the product with the information provided by industry, for example, the product trade name and its composition. The UFI is a unique code for each mixture composition which helps to identify the mixture and allows accurate and rapid medical advice to be given when there is a poisoning incident. The UFIs are generated with a tool available on ECHA's Poison Centres website and added to the labels.
What do I need to notify?
If you are an importer or downstream user placing a mixture on the market that is classified as hazardous for human health or as a physical hazard, you need to submit information on this to appointed bodies in the Member State where the mixture is marketed. The required information includes:
- the full chemical composition of the hazardous mixture; and
- the product category according to a new harmonised European product categorisation system (EuPCS).
There are some exemptions for mixtures classified for environmental hazards, medical devices, cosmetics, gases under pressure and explosives. All the information has to be compiled using a harmonised poison centre notification (PCN) format.
Currently, the poison centres’ emergency health advice is based on information that industry submits nationally in different formats.
The CLP Regulation was amended in 2017 to include the harmonisation of the information submitted across the EU. ECHA has since then released a harmonised submission format that will be used for notifications across the EU and which will replace national formats.
Currently, when a European company submits information on hazardous mixtures that are placed on the market in different Member States, it is done through national submission systems, which makes the information less consistent.
The PCN format is compatible with IUCLID software and takes advantage of this platform and its features. IUCLID is being further developed so that it provides a PCN-specific, user-friendly interface.
New portal with user-friendly interface
ECHA is working on a poison centres notification (PCN) portal that will allow industry to prepare and securely submit notification data to appointed bodies through a single entry point.
The portal is expected to be released in 2019. Different ways to prepare and submit notifications will be provided, including an online guide that will show step-by-step advice to prepare notifications, as well as options to notify large numbers of mixtures for bigger companies like a system-to-system integration. Building a user-friendly interface has been one of the main aims of this portal.
One of the most beneficial features for industry is the support for automatically translating standard data fields to other languages and the submission of this information to the Member States where you place your hazardous mixtures on the market.
The new functionalities will enable Member States to access the information from the notifications through the EU portal. All use of this central system is free of charge.
The launch of the portal in the beginning of 2019 is only the first step. A series of extended versions of the portal are being planned and could include more features such as:
- functionalities for national authorities to search, retrieve and view the notifications online;
- supporting the automatic verification of completeness of the incoming submissions;
- additional quality checks performed by appointed bodies;
- the possibility to annotate or flag potential issues found during the completeness and quality checks as well as recording the status of the review;
- aiding communication between national appointed bodies and submitting companies; and
- reporting capabilities on the notifications received.
ECHA has published an In brief publication with more details on the notification portal.
Start preparing for the submission
The deadlines for submitting the information in the new harmonised format are:
- 1 January 2020 for mixtures for consumer use;
- 1 January 2021 for mixtures for professional use; and
- 1 January 2024 for mixtures for industrial use.
These deadlines might seem far away but preparing now is in no way too early.
Start by identifying the mixtures that require submission, i.e. those that are affected by Annex VIII and the use of those mixtures. Are they for consumer, professional or industrial use? This will determine your deadline. If they are for industrial use only, you can submit less information provided there is a contact number for rapid access to more information in the event of an emergency.
You could also get to know the new EuPCS, which defines mixtures according to their intended uses; a product category will have to be allocated to each of your mixtures when submitting information.
If you have an IT provider that supports you, you should also contact them and consider the necessary next steps.
ECHA has updated the Poison Centres website with new pages on how to prepare for industry. If you have any questions, you can contact ECHA using the contact form.
Impact of the portal
We asked BASF, one of the large chemical producers, what impact the new portal would have for industry.
“Having a central notification portal with these features is definitely a strength in our view. It is valuable that we will now have a one-stop solution for the notification to all Member States in all the EU languages with automated features. It will definitely make life easier for industry,” says Ingolf Kuehn from BASF.
Also CEPE, the European Association of paints formulators, sees advantages for industry.
"We fully support the establishment of a central notification portal for Europe, which will facilitate compliance with the requirements for almost all companies. We urge all Member States to accept submissions through this portal, whether as the sole route or as an option in parallel to a national portal,” says Janice Robinson, Director for Product Regulations.
“Refusal to accept central submissions would increase the administrative burden for a significant number of duty holders and have a negative impact on the implementation of Annex VIII,” she adds referring to the Annex of the REACH Regulation on harmonised information relating to emergency health response.
Text by Jacob Aahauge
Published on: 13 September 2018
Top image: © IStock.com/Thaisign
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26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)