Poison centres: What leads to the obligation to update?
Article 45 and Annex VIII to CLP stipulate that all economic operators who place mixtures constituting health or physical hazards on the market in the EU, including Norway, Iceland and Liechtenstein, are obliged to submit a Poison Centre Notification. By definition, “placing on the market[…] means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market” (Article 3 (12) REACH).
Accordingly, the manufacture as well as the import of and trade with mixtures are considered as placing on the market. While notifications have been obligatory for hazardous mixtures for commercial and final consumer use since 1 January 2021, the corresponding deadline for mixtures for purely industrial use is 1 January 2024. Not only are affected companies obliged to make the initial notification, but they must also ensure that the submitted data is up to date at all times.
An update to an existing notification must be made when, according to the regulation, relevant changes occur and before the modified mixture is placed on the market. The current Guidance on harmonised information relating to emergency health response – Annex VIII to CLP provides information on all scenarios that entail an update of the notification.
These include changes of the trade name or classification with respect to health or physical hazards and the addition of new toxicological information. Changes to the formula of a mixture may also necessitate an update. Changes of information regarding the colour of the mixture, the pH value, the packaging type or size, and any spelling mistakes in the product identifier that need to be corrected, also lead to the obligation to update.
Formula changes and the UFI
The Unique Formula Identifier (UFI) is a supplementary labelling element and is linked to the formula of the mixture. Where there is a change of components mentioned in the notification, whether through addition, deletion or substitution, the UFI changes and the notification must be updated. An update is also required if there is a deviation from the standard formulas contained in Part D of Annex VIII of CLP regulation. Where a change in the composition of a mixture could be such that the mixture is no longer classified for health or physical hazards, the obligation to notify would no longer apply. Note that, in this case, too, a one-time update of the notification is required.
However, where the changes concern information about the trade name, new packaging, new toxicological data, classification of components or contact details of the legal entity, the UFI remains valid.
Annex VIII of CLP regulation specifies concentration ranges that apply to changes of the concentration of existing components. A notification update is mandatory only if the changes in concentrations exceed these ranges. It is important to note that the allowed variation always refers to the initial notification. This is to prevent that successive changes cause update notifications to be omitted. Updating the notification is not required by changing the concentration of components that do not have to be declared in the notification (e. g. non-hazardous components present in concentrations below 1 %). The options of changing the component concentration of mixtures with exact concentrations and of mixtures with concentration ranges is shown in Figure 1.
Influences of raw materials suppliers on the downstream user’s notification
If mixtures from a supplier are contained in a downstream user’s notified mixture (mixture in mixture; MiM), changes made by the supplier may have an impact on the downstream user’s notification for his mixture. Mixtures of raw materials can be identified by the supplier’s UFI or, if the supplier has not yet prepared an UFI, by the information of the supplier’s safety data sheet (SDS). Changes in the composition or of the hazard potential of MiMs may lead to the obligation of a new UFI for raw material. In that event, an update of the notification by the downstream user with a new UFI is required. Where a notification is based on SDS data and there is no supplier UFI, the changes might not be evident on the SDS. The originally notified formula of the downstream user therefore remains the same and the notification is not updated. If the MiM is present in very low concentration in the downstream user’s mixture, it may happen that a change to the composition of the raw material mixture does not require the downstream user to update. For example, if the supplier changes a non-hazardous component in the MiM that is present in the downstream user’s mixture at below 1 %, this component is not declared in the downstream user’s notification. The formula change of the MIM therefore has no influence on the initial notification of the downstream user. Often, however, the notifier does not possess exact information about the concentrations present in mixtures of raw materials. In case of doubt, a change in MiM compositions is therefore usually accompanied by an update of the downstream user’s notification.
Changing raw material suppliers, companies may be obliged to update notifications depending on the circumstances. No update is required if the raw material is a substance. It is also possible to confine to a comprehensive UFI for raw material if there are several suppliers or the supplier changes. However, this requires the raw materials to have identical compositions and hazard profiles. If the composition of the raw material varies in course of changing the suppliers, analogous procedure for a changed formula is to be followed and an update with a new UFI must be submitted.
The obligation to update poison centre notifications poses additional challenges for affected companies but is essential for providing enhanced emergency advice. The UFI ensures that products of different formulas with the same trade name can be clearly identified, as they can be in circulation at the same time. Here, the UFI enables accurate formula-based advice to be provided by the poison centres and thus avoids incorrect treatment.