March 23, 2022
Understanding poison center notification obligations for companies making & selling products classified as hazardous in Europe
In accordance with Article 45 of the EU Classification, Labelling and Packaging Regulation — the CLP Regulation — companies placing hazardous mixtures on the market are obliged to provide information to the relevant national bodies. A hazardous mixture could be a consumer product, for example, a candle or household cleaner. The national bodies make this information available to poison centres so that they can give advice to citizens or medical personnel in the event of an emergency. Annex VIII to the CLP Regulation (Regulation (EC) No 1272/2008), adopted in March 2017, defines the harmonized requirements for poison centre notifications (PCNs) applicable as of January 1, 2021.
The obligation to submit a PCN applies to all mixtures contained in consumer products classified for physical and human health hazards.
This includes cleaning products, detergents, all home fragrance products, adhesives, and inks.
Individual Member State Competent Authorities track the types of products being notified. If there is either an unexpected increase in a category of similar products being notified, or a spate of poisonings linked to a particular product type, then the authorities may launch reviews of that type of product to check and, if necessary, manage compliance.
The purpose, scope & definitions detailed in Annex VIII
Annex VIII to the CLP Regulation sets out the requirements that importers and downstream users placing mixtures on the market "shall fulfill in respect of the submission of information so that appointed bodies shall have at their disposal the information to carry out the tasks for which they are responsible under Article 45," namely emergency health response.
The submission of harmonized information requires the full chemical composition, the toxicological information, the label elements, a product category, other relevant product and mixture details, and the Unique Formula Identifier (UFI). The submitter shall create a UFI by electronic means made available by the European Chemicals Agency. The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures.
- Mixtures placed on the market for consumer use shall comply from January 1, 2021.
- Mixtures placed on the market for professional use shall comply from January 1, 2021.
- Mixtures placed on the market for industrial use shall comply from January 1, 2024.
The UFI code
It has been estimated that poison centres have difficulty identifying the correct product in about 40% of calls they receive. As a result, immediate and accurate advice can be compromised and may lead to overly cautious treatment. The concept of the UFI was developed to assist poison centres with the fast and correct identification of products during an emergency call when every second counts. In case of an accidental poisoning, the UFI code matters.
A UFI code is assigned to one (and only one) mixture. The UFI links a specific product on the market and the information submitted on the mixture it contains. The UFI itself does not reveal any confidential business information about the mixture, and only poison centres will know the formulation associated with the UFI.
While the UFI is another industry obligation, it can also offer benefits along the supply chain when communicating information about mixtures. For example, an upstream supplier can provide the UFI to a downstream formulator instead of disclosing the full composition, provided that the UFI and its relevant information have first been made available to the poison centre through the same submission obligations.
How Exponent Can Help
Exponent can compile the PCN dossier in the appropriate format (including generating the UFI) and submit it on your behalf through the European Chemicals Agency (ECHA) portal. We can also assist in the set up and management of the required legal entity ECHA account.