Now that the registration deadlines for existing chemical substances under the EU REACH Regulation have passed, the attention of the authorities is turning to chemical mixtures. Indeed, a new regulatory measure in the form of a harmonised EU Poison Centre Notification (PCN) is becoming highly relevant. A PCN notification must be submitted from 1.1.2021* onwards for hazardous mixtures in consumer or professional use, in case no notifications under national legislation exist for such mixtures.
For operators along the supply chain, preparations are needed well in advance in order to fulfill the information requirements of the novel notification format.
At the same time, at least the Finnish Safety and Chemicals Agency (Tukes) is holding on to the national obligation of notifying the authority of hazardous chemicals placed on the Finnish market. Although content-wise very similar to the PCN, the national notification also provides valuable information for the national authority’s chemical product register. During the transition period of the EU-wide notifications, the national notifications also continue to serve the needs of national poison centres until 2025 at least.
Heavy information requirements
Pursuant to the EU’s CLP Regulation, the PCN will cause challenges to the obligated importers and downstream users of mixtures placing their products on the market. Besides formulators, PCN submissions may also be necessary for refillers, repackagers and toll formulators. Distributors are not obliged per se, but have the opportunity to submit a PCN.
For each hazardous mixture, the following information needs to be notified to the Competent Authority:
- The unique formula identifier (UFI), consisting of 16 figures. The UFI code is dependent on the company’s VAT number. It links a specific product to the submitted information, enabling precise identification and rapid measures in case of emergencies.
- A categorization code in accordance with the European Product Categorisation System (EuPCS)
- Information on classification and labelling
- The precise mixture composition as concentrations of ingredients; very strict requirements for the concentration ranges
- Toxicological information on the mixture based on the Safety Data Sheet
- Information on physico-chemical properties, such as form, physical state, pH, colour
- Packaging type/size
If a formulator mixes two or more mixtures together with no information of the exact compositions of the original mixtures, the formulator can use the UFI codes of the original mixtures. However, this means that their suppliers will have had to create and submit their own UFI codes beforehand. Where no upstream UFI codes are available, it is also sufficient to provide the Competent Authority with the Safety Data Sheets of the original mixtures, along with the suppliers’ contact information.
Once a UFI code exists for a mixture, it will also need to be printed on the product label. The UFI code can be placed above the product bar code, for example. A re-labelling of all hazardous mixtures will therefore be necessary, sooner or later. The UFI code can be created using e.g. the UFI generator of the European Chemicals Agency (ECHA).
Hazardous mixtures in the spotlight
The PCN will be required of all mixtures placed on the market that are classified as hazardous for human health or on the basis of physical hazards. There are also some exemptions to the obligation. No notification is necessary for mixtures that are:
- Not classified as hazardous
- Only classified as hazardous to the environment
- Only classified as gases under pressure and explosives
- Used in scientific research and development
- Covered by the general exemptions of the CLP Regulation, such as radioactive mixtures, mixtures subject to customs supervision, medicinal and veterinary products, cosmetic products, food and feeding stuffs
The novel notification format is applied to hazardous mixtures for consumer and professional use from 1.1.2021 onwards, and for industrial use from 1.1.2024 onwards, respectively. If a national notification has been submitted and remains valid, i.e. the composition of the product or other significant information has not changed in the meantime, then the deadline for the PCN is by 1.1.2025 at the latest.
Internal actions needed
In view of categorising and re-labelling one’s own products, as well as updating the respective Safety Data Sheets and informing one’s supply chains, the creation of UFI codes should be commenced well before the final deadline of 2025. It is noteworthy, however, that the UFI code must first be submitted to the Competent Authority via the PCN before it is distributed in the supply chain.
In the future, this kind of information will not need to be submitted separately to each of the EU countries where one does business. With the new harmonised format, the same information can be made available to all of the Member States, should one choose so. However, relevant information will need to be provided in the required languages of the receiving Member States. Besides the European Union, the obligations of the CLP and REACH Regulations also apply to Norway, Iceland and Liechtenstein as members of the European Economic Area.
The PCN will be submitted via ECHA’s separate Submission Portal. Some Member States also allow submissions through their own portals. The contents of the PCN will require significant changes from the submitting companies to their product categorisation and listing systems. The easiest way to create a PCN is through the IUCLID software maintained by ECHA.
In a nutshell, the time for action is now, starting with an inventory of the company’s product portfolio. And in case of any doubt, we will be more than happy to help!
*The EU authorities have agreed to postpone the application date of the Poison Centre Notification for mixtures in consumer use to 1.1.2021. The original legislation had set the application date for consumer use to 1.1.2020, already.