Submitting information on hazardous mixtures to poison centres
Importers and downstream users have a legal obligation to submit information to poison centres when placing hazardous mixtures on the EU-market. The obligation applies to mixtures that are classified as hazardous on the basis of their health and physical effects. The obligation is based on the European CLP Regulation (Regulation (EC) No 1272/2008).
As stated in article 4(10), all operators in the supply chain have the obligation to make sure they place on the market mixtures which are in compliance with CLP as a whole. This means that also distributors (in particular rebranders/relabellers or companies distributing a mixture in another Member State) may need to submit the information themselves if the relevant information is not included in a submission made by the supplier. The poison centres of all the countries in which the mixture is to be placed on the market must be notified.
At the moment, companies can fulfil their notification obligation by submitting a Chemical Notification of dangerous or hazardous chemicals they manufacture or import to the relevant authority. In Finland the notification shall be made via the KemiDigi online portal pursuant to section 22 of the Finnish Chemicals Act. From 1 January 2021 onwards notifications to the Finnish Poison Information Centre is made via the ECHA (European Chemicals Agency) Submission Portal. Furthermore, a Chemical Notification shall still be made in addition to the Finnish Safety and Chemicals Agency for other purposes.
Poison Centre Notification (PCN) – when and how?
The information required in the notifications is listed in Annex VIII of the CLP Regulation. Submissions should be made in the harmonised format, according to the relevant date of applicability. The date of applicability depends on the use type of the mixture as follows:
- mixtures for consumer use as of 1 January 2021,
- mixtures for professional use as of 1 January 2021
(intended to be used by professional users but not at industrial sites), and
- mixtures for industrial use as of 1 January 2024
(intended to be used at industrial sites only).
Following information is required in the notifications:
- product identifier,
- details of the downstream user or importer,
- classification of the mixture for health and physical hazards,
- information included in the label,
- information about toxicity, and
- information on mixture components and generic product identifiers.
Each mixture will have a Unique Formula Identifier (UFI), which the downstream user or importer generate using an application on ECHA’s website before the notification.
There is no charge for registering UFIs. The UFI must be mentioned in the PCN and shown in the product label or in its immediate vicinity. Mixtures for industrial use and unpackaged mixtures are an exception: including the UFI in the chemical safety data sheet is enough.
A transitional period can be utilized for all products that are previously notified to the Finnish Safety and Chemicals Agency and which are already on the market. Such notifications will remain valid until 1 January 2025 or until changes are made to the product. A notification complying with Annex VIII of the CLP Regulation must be submitted via the ECHA Submission Portal if any changes are introduced to the mixture composition, product identifiers, toxicological properties or classification of an existing mixture.
The ECHA Submission Portal is open, and some Member States already accept poison centres notifications via the ECHA Submission Portal. The ECHA keeps a list of individual Member States’ procedures. Notifications can be made to Finland from the beginning of 2021. Notifications made prior to this via the PCN Portal shall be deemed to have been made on 1 January 2021.
For the latest information, instructions and tools/applications, visit the Poison Centres website.
CLP Regulation (Regulation (EC) No 1272/2008
ANNEX VIII: Harmonised information relating to emergency health response and preventative measures
ECHA's Guidance on Annex VIII
The Guidance on harmonised information relating to health emergency response - Annex VIII to CLP – is available in 23 EU languages.