The information provided to the Poison Centre must remain accurate, complete and up to date throughout the entire period during which the mixture is made available on the market.
- When must a notification be updated?
In accordance with Annex VIII, Part B, Section 4.1, of Regulation (EC) No 1272/2008 (CLP), a notification must be updated when certain changes occur after the initial notification.
An update is required in particular when:
- the name of the mixture or its product identifier changes;
- the UFI changes;
- the classification of the mixture with regard to its health hazards or physical hazards changes;
- new toxicological information concerning the hazardous properties of the mixture or its components becomes available;
- the composition of the mixture is modified under the conditions laid down in Annex VIII.
- Modification of the composition
A change in composition may require an update of the notification and the creation of a new UFI.
Annex VIII provides in particular for an update when one or more relevant components are added, replaced or removed, or when their concentration is changed beyond the limits laid down in Annex VIII.
Where concentration ranges have been declared, an update is required when the new concentration falls outside the declared range.
Where exact concentrations have been declared, an update is required when the change in concentration exceeds the limits laid down in Table 4 of Annex VIII.
In these situations, the change in composition is considered significant: a new notification must be created and a new UFI must be used.
Conversely, when the change in concentration remains within the limits laid down in Annex VIII, no update of the notification and no new UFI is required on this basis.
- When is a new UFI required?
The new UFI is linked to the rules applicable to changes in composition.
When a change in composition exceeds the limits laid down in Annex VIII and requires a new notification, a new UFI must be created.
Certain changes that do not concern the composition may require an update of the notification without requiring a new UFI, depending on the conditions laid down in Annex VIII.
- Voluntary updates
Certain information may also be changed where the change does not trigger a mandatory update under Annex VIII, Part B, Section 4.1.
This may include corrections or changes to information useful for responding to a health emergency, such as certain contact details, packaging information or other data provided.
This information may be updated voluntarily so that the data available to the Poison Centre remain relevant and up to date.
In the case of a voluntary update that does not concern a change in composition requiring a new UFI, the UFI does not need to be changed.
- When should the update be made?
When a change covered by Annex VIII results in an obligation to update, the information must be updated before the modified mixture is placed on the market.
It is therefore important to check the information provided to the Poison Centre whenever a change is made to the product, its classification, its composition or information relevant to the management of an exposure.
- Biocidal products and plant protection products
For biocidal products and plant protection products, any change to the product must be assessed in light of the regulatory requirements applicable to it, in particular the conditions of its authorisation, registration or placing on the market.
Where this change results in a change to the information previously provided to the Poison Centre, the notification must be updated in accordance with the applicable rules.
Updating the notification with the Poison Centre does not replace any procedures or applications that may need to be undertaken with the competent authority as part of the authorisation, registration or placing on the market of the product.
Companies must therefore check with the relevant competent authority, before making any change to the product, which regulatory obligations apply.
- Practical information
For practical information concerning the updating of notifications, companies can consult the guidance and information published by the European Chemicals Agency (ECHA), in particular the Guidance on harmonised information relating to emergency health response, under Section 7.4 Keeping the information up to date
Regulatory reference: Regulation (EC) No 1272/2008 (CLP), Annex VIII, Part B, Section 4.1.