Implementing the first step of the Article 45 CLP-Regulation

Objective: Since 20 January 2009, the EU-CLP Regulation (EC) No. 1272/2008 (Classification, labelling and packaging of substances and mixtures) has been in effect. Article 45 stipulates compulsory reporting of formulations of mixtures by industry for emergency health services. For adaptation of the CLP Regulation on a national level, the German government implemented Art. 45 CLP-Regulation into the § 16e (Chemicals Law - Chemikaliengesetz). For a transition period (9th November 2011 limited to the 1st July 2014) German industry can already start to use “Art. 45-Electronic Product Notification” via an adapted BfR-Electronic Product Notification Portal. Methods: Since 2007, notification of formulations of detergents and cleaning agents has been performed by file transfer in XML-format. This procedure was developed by the BfR and had been well adopted by industry. This format was refined by the BfR to ensure that data on all notifiable products and data reported on a voluntary basis can be transmitted in XML-format. This prototype and the procedures have been practice-tested in cooperation with a major enterprise (Henkel, Düsseldorf). After final testing the BfR-database has been adapted to the new requirements of the CLP-Regulation on e.g. labelling and all important data, including clear identifiers (e.g. product identification element) which can be exchanged in the new format. Results: The § 16e (new) has been successfully adapted to the CLP Regulation (EC) No. 1272/2008: 1) governed by public law with a transition period in awaiting the EU-harmonisation dataset for product notifications and 2) technical in having an adapted BfR-XML Electronic Notification Portal which carries all the requirements for the rapid adaptation to the future EU standard data set. With the new § 16e the notification of dangerous mixtures is considerably extended. Products with all hazard identifiers – commercial/non-commercial – have to be notified. The increase is already visible in 2012. From January to October 38,735 dangerous mixtures (excluding biocides) had been notified. This represents a 25-fold increase compared to 2011. Conclusion: A universal electronic notification procedure for industry will enable BfR to considerably increase the number of product notifications received, processed and communicated to German PCCs.