Anyone considering the use of the transitional period for their products, i.e. up to 2025, needs to know when a repeat notification of mixtures is required. The first European product notification will commence in 2020. Currently, it is still possible to carry out a BfR product notification for mixtures and then, from 2025 onwards, fulfil the harmonised European notification requirement, even if UFIs have already been used in accordance with Annex VIII of the CLP Regulation. Very convenient, though not always very useful.
It is of little use if, up to that point in time, a mixture is going to change to the extent that it requires a new notification in accordance with the European notification rules. In such cases, harmonised notification will already apply before 2025.
Why is a repeat notification requirement for mixtures required at all?
It is well known that product formulations can change over time, for example to fulfil new requirements. This may also have implications in terms of their hazard risk characteristics. The purpose of product notifications is to provide the relevant authorities (poison information units) with information so they are prepared for emergencies and will be in a position to assist users. However, if the composition changes, an update to this information is required. This is achieved by repeat notification of mixtures with the relevant new information.
When is a new notification required?
The new European-wide product notification specifies the exact point in time the mixture requires renewed notification. In general: Notification is required before the modified mixture enters the market. Possible reasons for a mandatory update include:
Changes to the product identifier, including the UFI. A change to the product designation obviously requires new notification.
Classification change. If there is any change to the classification in Section 2.1, in relation to physical dangers or health hazards. Changes to environmental hazards are therefore not relevant.
If new toxicological information (Section 11) is available. The European notification also includes information from Section 11. Accordingly, changes to this information require a notification update.
Certain changes to the composition of the mixture. Not every change results in a new notification requirement. If a component that requires notification (according to CLP, Annex VIII, Part B, 3.3) is removed or added, an update is required. This get a bit more complicated when it comes to changes to the concentration. If the concentration changes over the range of concentration, a new notification is required.
If the range of concentration stays the same, the following modifications are decisive:
- More than 25% up to 100%: Update if ±5%
- More than 10% up to 25%: Update if ±10%
- More than 2.5% up to 10%: Update if ±20%
- 2.5% or less: Update if ±30%
Conclusion – When would it make sense to avail of the transitional period?
In summary: For minimal changes to the composition of a product that is sold under the same name, BfR product notification to extend the transitional period until 2025 for Germany may be worthwhile. Care should be taken with UFIs of own product mixtures, however.
This part concludes my insight into the harmonised European notification for hazardous products. What is going to happen up to the first deadline at the beginning of 2020 will most likely be influenced by the outstanding ECHA feasibility study and I will keep an interested eye on further developments.
Sources: Workshop on implementation of Annex VIII to CLP
Internet presence Poison Centres