Notification of Products
There is a wide range of chemical products on the market for a variety of applications, and these products can contain a broad spectrum of different ingredients. In order to protect consumers from health risks originating from these substances, the responsible companies are legally under an obligation to provide the German Federal Institute for Risk Assessment (BfR) with comprehensive information regarding many of their products.
The BfR, as a federal authority, is responsible for forwarding this information to all of the poison centres in Germany (PDF file,26.00 KB).
Article 45 of the European CLP Regulation and Article 9 of the European Regulation on Detergents form the statutory basis for this notification obligation. The requirements of these European regulations have been implemented into national legislation, which partly specifies these requirements in more detail.
Article 16e of the German Chemicals Act (Chemikaliengesetz), for example, stipulates requirements for the notification of hazardous mixtures. Moreover, the German Poison Information Regulation (Giftinformationsverordnung) specifies the notification requirements in more detail.
In the same way, Article 10 of the German Detergent and Cleaning Agents Act (Wasch- und Reinigungsmittelgesetz) stipulates notification obligations for detergents and cleaning products not classified as hazardous. In addition, Annex VII, section C of the European Regulation on Detergents specifies minimum requirements for these products. The stipulations of the German Chemicals Act and the German Poison Information Regulation (Giftinformationsverordnung) govern notification requirements for detergents and cleaning products classified as hazardous. Exemptions are in place for detergents and cleaning products subject to the national transitional provision as outlined in Article 28 (12) of the German Chemicals Act.
In addition, the BfR also accepts information on products which are not subject to any of the notification obligations. This information is also forwarded to the poison centres, as it may be of relevance in the event of an emergency health response.
The BfR and all poison centres treat all received information on products in strict confidence.
Notification to the BfR is free of charge.
European Harmonisation for Product Notifications
When the European CLP Regulation entered into force in January 2009, this triggered the beginning of the process of harmonisation for product notifications within the European Economic Area. The aim was to introduce comparable public health standards in the EU as well as in associated countries and to facilitate product notifications, particularly for companies with activities throughout the EU.
The Annex VIII to the CLP Regulation (see (EU) 2017/542) contains the harmonised format for notifications of mixtures (PCN format) for submission to the appointed bodies of the member states. The BfR is the appointed body for Germany. This format harmonises notifications regarding both content and technical format within the member states in a legally binding way. In January 2020 a 1st revision of Annex VIII was published (see Delegated Act (EU) 2020/11) resulting in adjusted compliance dates. Notifications of mixtures (products) shall comply with this Annex; in the case of products for
- Consumer use and professional use from 1 January 2021
- Industrial use from 1 January 2024
In addition Annex VIII has also been modified regarding content aspects by the above mentioned act.
You will find more information on the European harmonisation of the notification of mixtures classified as hazardous on the Poison Centres Website of the European Chemicals Agency (ECHA):
On this website information is provided on
- the content-related Guidance Document
- the latest version of the technical notification format (PCN Format)
- technical Guidance Documents for the process
- the European Product Categorisation System (EuPCS) and
- the Unique Formula Identifier (UFI).
A link is provided to the ECHA Submission Portal (Poison Centres Notification Portal - PCNP): Since 24 April 2019 companies have got the possibility of submitting their notifications to BfR via PCNP instead of uploading directly to the national BfR Portal. This facilitates submissions for companies marketing products in more than one EU member state. After technical validation ECHA provides the notifications intended for Germany to BfR. The national BfR notification portal (see below) will remain for direct notifications. No confirmation letters will be posted for product notifications received by BfR via PCNP. Information on a successful submission can be obtained by the notifier from the PCNP itself. BfR performs a validation regarding content of all product notifications. If necessary and in accordance with Article 45 paragraph 3 of the CLP regulation BfR may claim additional information or adjusted notification files.
Current Amendments to the National Legislation
Most recent amendments to the national legislation came into force in December 2019. As a consequence, the national notification provisions according to the German Chemicals Act in the version valid until 31 December 2019 remain in force concerning consumer and professional products until 31 December 2020. This results from the postponement of the notification obligations for consumer products, according to the revised Annex VIII to CLP, to 1 January 2021. Hence the notification can still be performed in accordance with Annex 1 to the German Poison Information Regulation (Giftinformationsverordnung) in the version formally valid until 28 July 2017. (PDF file,124.69 KB) Notifications shall be performed using the XProductNotification format provided by the BfR. Alternatively there has been the option of using the European harmonised notification format (PCN format) according to Annex VIII CLP since April 2019. Notifications using the PCN format may be submitted among others via the ECHA Submission Portal (PCNP) (see above). The national transitional provision has also been adjusted in the context of the postponement of notification obligations for consumer products according to Annex VIII CLP.
The national transitional provision of Article 28 para. 12 of the German Chemicals Act, which currently applies to some products (mixtures) classified as hazardous and which permits limited notification, pertains for
- Products (mixtures) for private use (consumer products) and professional use until 31 December 2020 and
- Products (mixtures) for industrial use until 31 December 2023
until Annex VIII to the CLP Regulation comes into force.
Product Notification - Procedure
1. Application for a BfR Company Code
A BfR company code is still required for notifications in the national notification format to the BfR. Please find the required form here (PDF file,589.16 KB).
National notifications are processed using the electronic XML format XProductNotification. The responsible companies can generate notifications automatically or using an electronic notification assistance program. A Microsoft Excel version (ZIP archive with files for all product notifications (XProductNotification.zip) (PDF file,3.46 MB)) and an OpenOffice Calc version (ZIP archive with files for all product notifications (XProductNotification_OpenOffice.zip) (PDF file,2.11 MB)) including manuals are provided by the BfR.
Alternatively notifications may be made in the format of Annex VIII to CLP and directly submitted to the BfR as well.
3. Data transmission
A portal page ensures secure data transmission to the BfR.
Helpdesk (in German and English)
For general queries regarding legislation on chemicals, please contact the REACH-CLP-Biocide Helpdesk of the German Federal Institute for Occupational Safety and Health (BAuA); for general queries concerning detergents and cleaning agents legislation, please contact the German Environment Agency (UBA).