The easy implementation of Art. 45 of the CLP Regulation is not a simple matter, as the well-attended workshop of the Chem-Academy on May 15th once again demonstrated. The event, aimed at product safety managers, consisted of a practical workshop, in addition to presentations from industry experts and the authorities involved. Alexander Wegener, CEO of opesus AG, and Markus Pogrzeba, Product Manager at opesus, were able to share their know-how and experience as workshop leaders and lecturers.
Relevant Lectures – Close to Everyday Working Life
Dr. Rafael Wagner from the Poison Information Centre North (Giftinformationszentrum-Nord; GIZ) in Germany explained what benefits both commercial users and private consumers can derive from the product information for the GIZ and why certain information is required.
Kathrin Begemann from the Exposure Department of the Federal Institute for Risk Assessment shed light on the national implementation of Art. 45 CLP regulation, the technical challenges companies are facing and the procedure for generating UFIs. She also discussed the rules for updating notifications and the handling of mixtures in more detail. As a useful insight, she also provided information on who is responsible for the implementation within a company.
Dr. Friederike Paven of Covestro Deutschland AG gave practical tips and shared her experiences on how to master the challenges of implementing Annex VIII. She explained the effects of the regulatory changes on a multinational chemical manufacturer, challenges in the implementation of the information obligation for mixtures, and experiences with sector-specific solutions. She also addressed the protection of intellectual property as an important issue.
Last, but not least, Marin Merkl, Head of Regulatory Intelligence at Merck KGaA, offered a checklist for implementing reports to GIZ. She addressed data quality criteria and answered questions about supplier-customer relationships, labelling challenges and product portfolio reviews.
The topics discussed were very far-reaching and close to everyday working life. As a software and consulting company, and thanks to the close working relationship with ECHA, opesus was able to provide valuable information and experience on which data sources must be included, what the system architecture can look like and what the technical requirements for automated product notifications are. In addition, the creation of a realistic time schedule, budgeting, and project management were topics of the workshop.
Practical Exercises: What Impact Does Art. 45 CLP Regulation Have on my Company?
In the practical part of the workshop, we worked on evaluating the effects of Art. 45 CLP regulation for the respective companies and work areas of the participants. The first considerations were which deadlines and roles apply to the participants’ companies, with whom to communicate to in order to obtain or pass on information, and in which countries to report at all.
Subsequently, the next step was discussed: In which existing systems can the data to be reported be found? Only by knowing where to find the relevant data can a realistic assessment be made at a later stage as to how the data can be reported to ECHA on time.
Another task was to identify the products to be notified per Member State, broken down into existing products, new products, and annual changes. From the sum of these, the number of product notifications to be made per year was calculated individually for each participant.
Now that the valid deadlines and the products to be reported had been listed and the data to be reported had been found in the system landscape, there was one final task: the analysis of the relevant IT systems.
With all this information it was now possible to define which procedure for reporting the relevant data is appropriate for the respective company. For this purpose, a checklist with points to be considered and an exemplary project plan were provided. In this way, each participant developed a relevant and individual plan for their company.
To conclude, Alexander Wegener and Markus Pogrzeba gave three important hints to the participants:
- The challenge should not be underestimated and is the biggest since REACH came into force.
- The possibilities to protect company secrets should be used
- Start early!
The event provided a well-rounded picture of the challenges of Art. 45 CLP regulation in general and provided practical support for each individual participant by means of the workshop elements. The format convinced both the participants and us and we are looking forward to leading and moderating the next workshop!