The German Federal Institute for Risk Assessment (BfR) is the appointed body for receiving product notifications and forwarding them to the various poison centres in Germany. As the main responsible body, the BfR also checks product notifications for completeness and accuracy and work hand-in-hand with the European Chemicals Agency (ECHA).With the CLP Art. 45, Annex VIII requirement, the majority of product notifications are submitted centrally to the ECHA and then sent to the BfR who then ensures that the information is available to the German poison centres.
Welcome and Introduction
Prof. Dr. Matthias Greiner of the BfR welcomed all the participants, both onsite in Berlin and online to the 12th BfR User Conference. The hybrid-style conference took place on 15th November 2021. He introduced the BfR as an institute and the speakers of the conference:
- Dr. Herbert Desel - BfR, Berlin
- Mette Ekeland - Norwegian Poison Information Centre, Oslo, Norway
- Daniele Ape - European Chemicals Agency (ECHA), Helsinki, Finland
- Heide Rasikari - ECHA, Helsinki, Finland
- Dr. Ronald Keipert, Ester Feistkorn, Dr. Sebastian Pfeifer - BfR, Berlin
Here are some highlights from the conference:
Status Update After the First Compliance Date (1st January 2021) from ECHA
January 1st, 2021, marked a major change in the notification requirements for hazardous chemical mixtures. Under the CLP regulation, all companies that place mixtures on the EEA markets that are classified for health or physical hazards are required to notify their products to the ECHA Submission Portal. The first deadline applies to mixtures for consumer and professional use.
Dr. Herbert Desel from the BfR and Daniel Ape from ECHA reported on a wave of EU Poison Centre Notifications (PCN) that came in at the end of 2020 and especially at the beginning of this year. While the BfR normally receives 10 notifications per day over the last few years, they now receive an average of 1000 notifications per day since January 2021. To keep up with the number of notifications received daily, the BfR will be upgrading its technical infrastructure to serve the national poison centres in the best and most efficient way possible.
Mr. Daniele Ape of ECHA states that by November 2021, more than 2 million EU PCN notifications had been received. 80 percent of these dossiers were reported by companies using system-to-system (S2S) interfaces. The majority of notifications are done by our customers using opesus EPN, see this blog article.
What important changes might be waiting for us next?
At the moment, the European Commission is examining and discussing if and when the scope of CLP Annex VIII should be extended to hazardous substances. Should this be the case, then it is also conceivable that the UFI must be applied to hazardous substances and notifications need to be submitted in a predefined C&L format to the ECHA Submission Portal.
Additionally, further development can be expected with regards to the legal obligations of distributors of hazardous mixtures. Distributors could soon be obliged according to CLP Regulation Article 45, Annex VIII to submit product notifications (PCN format) for hazardous mixtures.
Insights from the German and Norwegian Poison Centres - the UFI makes a difference!
In Germany, there are seven Poison Centres providing advice to approximately 73,000 calls received per year. In Norway, there are two Poison Centres which receive approximately 47,000 calls. In both countries, the average consultation time is about 4 minutes. With the introduction of the UFI, the poison centres can more quickly identify the mixture in the poisoning case. Therefore, the combination of the UFI and product name have an overall positive impact in emergency response - search time is reduced, and the quality of advice is improved. To increase awareness among consumers about the UFI, ECHA launched an EU-wide social media campaign.
We’re glad that this annual conference was organized as a hybrid. This allowed us to reconnect personally with colleagues at the BfR and get to know new faces and other participants. We look forward to attending the next one!