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Notifications of formulations

The spectrum of different products for diverse uses is extremely large. The products are based on exactly defined formulations with a variety of ingredients. In order to protect consumers against health risks manufacturers, product launchers or distributors must notify the formulations along with the ingredients for various product groups to BfR.

The legal foundations for the notification of formulations are set out in various laws (Chemicals Act, Biocides Ordinance, Cosmetics Ordinance, Detergent and Cleaning Agent Act). They serve consumer protection and are mostly enactments of different European legislation.

BfR treats the information on the properties and composition (formulations) of products contained in the poison information database confidentially. The poison information and treatment centres only disclose as much information as is needed to treat a case of poisoning. Consumers are informed of emergency measures.

Information about formulations is not disclosed. The only people who have access to the poison information database are the staff members from the poison information and treatment centres whose names have been passed on to BfR by the federal states.

Which formulations must be notified for the purposes of documentation in the poison information database?

• Hazardous mixtures (Chemicals Act § 16e)
• Biocides (Chemicals Act § 16e)
• Detergent and Cleaning Agents (Detergent and Cleaning Agents Act § 10)
• Voluntary notification

Products may be notified electronically or using the forms provided in the German Poison Information Regulations (Giftinformationsverordnung – GiftInfoV).

Electronic product notifications

All product notifications can be submitted to BfR in electronic form.

For submitting an electronic notification, a BfR company code is required. The latter can be obtained from BfR on request in writing (email is also acceptable). A corresponding form is available for downloading in the Documents section at the bottom of this page. The data to be specified include:

• Company name
• Complete address, and
• Person to be contacted in cases of emergency

Electronic product notification using the XProductNotification exchange format

Notifiers may read out their data from an existing database and generate a notification file in the XProductNotification format, using their own software.

For companies unable to generate an XML file, BfR has developed electronic notification assistance in the form of an Excel file (defined columns) including a macro to generate the XML exchange format (XML file), and a user manual.

Documents provided by BfR for all product notifications in the ZIP archive (XProductNotification.zip) in the section on the right side and at the bottom of this page include

• Definition of the XProductNotification format (XProductNotification.xsd)
• Description of the format (XProductNotification_Data_Exchange_Format.pdf)
• Notification assistance Excel file (XProductNotification_BfR.xls)
• Notification assistance Excel example (XProductNotification_BfR_example.xls)
• Notification file example (XProductNotification_BfR_example.xml)
• User Manual (XProductNotification_Acquisition_using_Excel.pdf)

Transmission of data for product releases

BfR has developed to transmit the data, a portal site with secure Internet connection.

You can also send data to BfR.

Address:

Bundesinstitut für Risikobewertung
Vergiftungs- und Produktdokumentation
Max-Dohrn-Str. 8-10
D - 10589 Berlin

E-Mail: produkt-meldungen@bfr.bund.de

Helpdesk

Renate Kolbusa
Tel.: +49-(0)30-18412-3902

Dr. Ronald Keipert
Tel.: +49-(0)30-18412-3912

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