Product notifications: Why do companies have an obligation to notify?

16.02.2024 2:43

1. Any Questions?
2. Legal Basis for the Product Notification Requirement
3. Which Products Require Notification?
4. Exemptions from the Notification Requirement
5. Who Is Required to Provide Notification in Germany?
6. European Harmonised Notification: Poisons Centres Notification (PCN) and
   Unique Formula Identifier (UFI)
7. Dossier Creation and Transmission of Product Information
8. Submission of PCN Notifications via the European Chemicals Agency (ECHA)
9. Submission of PCNs Directly to BfR
10. Further Information
11. Transitional Provisions and PCN Process
12. Data Protection and Data Safety
13. Costs
14. Information on Safety Datasheets (SDS)

Which formulations have to be disclosed? Compositions of chemical products are usually valuable confidential business information. Since knowledge of product composition is highly relevant for administering proper medical advice and treatment, it is mandatory to provide notification of such products before launching them on the market.

The information obtained in the notifications is stored in the BfR product database and made available to the poisons centres (GIZ) of the German federal states to support their medical response capabilities. Product notifications in Germany are free of charge.

Any Questions?

If you have any questions about the procedure, please contact the BfR Helpdesk for Product Notification (technical questions) or the REACH-CLP Biocides National Helpdesk (legal questions).

Legal Basis for the Product Notification Requirement

To ensure that proper medical advice can be provided by the German poisons centres, legal entities importing or launching product mixtures classified as hazardous in the European Economic Area (EEA) are legally obliged to notify the competent authority and provide relevant information about these products. The competent authorities are the appointed bodies of the respective EEA countries.The German Federal Institute for Risk Assessment (BfR) is the appointed body for Germany.

For that reason the BfR is responsible for receiving notifications from the companies, as well as data processing and subsequent forwarding of the information to the Germany’s poisons centres.

Article 45 of Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP) and § 16e of the national Chemicals Act both provide the legal basis for the notification requirement.

• Regulation on Classification, Labelling and Packaging of Substances and Mixtures
• Chemicals Act

The content of the regulation and the notification procedure are explained below.

The format of EEA-wide harmonised notification is the Poison Centres Notification Format (PCN Format). The details of the Poison Centres Notification Format are given in Annex VIII to the CLP.

Which Products Require Notification?

Product mixtures classified as hazardous on the basis of their health and physical effects are subject to notification requirements as outlined in Art. 45 of the CLP Regulation. The classification of substances and mixtures is stipulated in Art. 3:

'A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.

Where, in Annex I, hazard classes are differentiated on the basis of the route of exposure or the nature of the effects, the substance or mixture shall be classified in accordance with such differentiation.'

Information on products classified by virtue of their health and physical properties must be submitted in form of product notifications to the appointed bodies. The BfR is the appointed body in Germany.

Exemptions from the notification requirement are described in the following chapter.

Please note: Through its REACH-CLP-Biocide Helpdesk, the German Federal Institute for Occupational Safety and Health (BAuA) serves as official contact point for queries on the classification of substances and mixtures, as well as on the Classification and Labelling (C&L) Inventory hosted by the European Chemicals Agency (ECHA).

Exemptions from the Notification Requirement

First of all the general exemptions apply as outlined in Art. 1 para 2 of the CLP Regulation. Further exemptions result from Art. 45 and Annex VIII of the regulation.

As a consequence, further exemptions apply for:

1. Substances
2. Mixtures classified for environmental risks only or with additional labelling only
3. Mixtures for scientific research and development
4. Mixtures for product and process orientated research and development
5. Mixtures classified only for one or more of the following physical hazard:
   1. Gases under pressure
   2. Explosives (unstable explosives and divisions 1.1 to 1.6)

Please note: 'Bespoke paints' (paint mixtures formulated on customer’s demand at the point of sale, e. g., in DIY markets) are not exempted from the notification requirement. However, a separate condition is in place instead.

In addition, an abridged form of notification (‘limited submission’) may be submitted for mixtures that are intended exclusively for industrial use, i.e., use in industrial settings, and of mixtures whose end use lies outside the scope of Art. 45, provided rapid access to the complete product information is maintained at all times (see Appendix VIII Part A 2.3).

You can find detailed information on these exemptions via the REACH-CLP-Biocides Helpdesk of the German Federal Institute for Occupational Safety and Health (BAuA) and from the Guidance on harmonised information relating to emergency health response - Annex VIII to CLP.

The BfR also accepts information on products outside the scope of Art. 45, so-called voluntary notifications. This product data is also forwarded to the poisons centres for emergency health purposes. More information on voluntary notifications is provided here:

• Voluntary Notifications

Information on product notifications for detergents and cleaning agents can be found here:

• Notification for Detergents and Cleaning Agents

Who Is Required to Provide Notification in Germany?

According to Art. 45 (1) of the CLP Regulation the following parties are required to provide notification:

• Importers based in the EEA importing product mixtures classified as hazardous from outside the European Economic Area
• Downstream users launching product mixtures classified as hazardous on the market:
• Manufacturers of a mixture (Formulator)
• Toll formulators
• Refillers
• Repackers

German law also requires the following parties to provide product notification:

• Relabellers and Rebranders

Additionally, an indirect product notification requirement arises from Art. 4 (10) of the CLP Regulation. Accordingly all parties in supply chains, even distributors, have to comply with all of the requirements of the CLP Regulation before a new product can be launched.

All relevant information required to mount an emergency medical response (i.e., notification according to Art. 45) must be available to each of the EEA member states where the product is intended for sale.

You can find detailed information on notification requirements via the REACH-CLP-Biocides Helpdesk of the German Federal Institute for Occupational Safety and Health (BAuA) and from the Guidance on harmonised information relating to emergency health response - Annex VIII to CLP.

European Harmonised Notification: Poisons Centres Notification (PCN) and Unique Formula Identifier (UFI)

The Poisons Centres Notification procedure has been developed to harmonise the submission of product information in the European Economic Area (EEA). The PCN process is mixture-based, i.e., all products sharing the same mixture composition may be pooled in a single notification (a dossier). A Unique Formula Identifier (UFI) is generated for each composition and within the notification linked to the composition. Afterwards the UFI is printed or affixed on the label or packaging.

Further information on the Universal Formula Identifier (UFI) is available here:

• UFI Generator

The European Chemicals Agency (ECHA) is responsible for development, maintenance and updating the

• PCN Format
• Tools and guidance documents regarding the notification process
• ECHA Submission Portal (ESP)
• Distribution routes to the member states

For this reason, the ECHA has been assigned a central role in this process as receiver and dispatcher of product notifications in Europe.

A PCN is also called as dossier. Technically, dossiers are data files in IUCLID6 format. The BfR receives all dossiers from the ECHA containing those products which have been designated for launch in Germany. Eventually the product information is forwarded by the BfR to the German poisons centres.

Dossier Creation and Transmission of Product Information

There are different ways to generate a dossier:

• IUCLID software (offline installable version)
• IUCLID cloud (browser-based online tool)
• Company’s own software application with or without a system-to-system connection directly to ECHA (S2S, software commercially available)

Further information is provided on the website of the European Chemicals Agency (ECHA).

PCN dossiers have to be submitted to all the member states where the respective products are intended for sale. Belgium, France, Latvia, Portugal and Germany receive notifications directly (as of April 2021) about products, which are intended for their national markets. As an alternative, notifications for all EEA countries, including those mentioned above, can be submitted via the Submission Portal (ESP) of the European Chemicals Agency (ECHA). This method facilitates product submission, in particular for companies operating across the continent, since dossiers (or simply one single dossier per composition) can be submitted to all countries in one go. The ECHA is responsible for transferring the notification data to the respective member states.

Both methods of submission are explained below.

Please note: For both methods of submission, the BfR can request additional information or clarification even after formal acceptance (Art. 45 (3) / Annex VIII Part A Section 3.2 CLP Regulation.

Submission of PCN Notifications via the European Chemicals Agency (ECHA)

A product notification is submitted as a dossier in PCN Format (i6z file) via the ECHA Submission Portal (ESP). The introduction of this portal for the entire European Economic Area offers the advantage that notifications of products sharing the same composition can be submitted to all the relevant EEA member states at the same time.

• To ECHA Submission Portal (ESP)

After a dossier has been submitted via the ECHA portal, a link to a dedicated Submission Status Page will be provided to the submitter. The current status of the submission is displayed in the Submission Events section.

Product notifications intended for Germany are sent to the BfR by the ECHA. Receipt of a notification by the BfR signals the formal fulfilment of the notification requirement (Submission Event: Dossier received by DE). This status entry is the only confirmation of a successful notification submission via the ESP. No further confirmation will be posted by the BfR.

Submission of PCNs Directly to BfR

Notifications containing products which are designated exclusively for the German market can be submitted directly to the BfR.
These notifications have to be submitted to the BfR in PCN Format (i6z data file).

Please use the BfR web portal to transfer your files.

• To national BfR Web Portal

For all product notifications sent directly to the BfR, in contrast to notifications via the ECHA portal (ESP), the BfR provides confirmation of formal acceptance via postal correspondence, which is sent to the person issuing the notification.

Further Information

• PCN procedure
• PCN Format
• ECHA tools (e. g., UFI generator)
• PCN: A practical guide (important hints on PCN notifications via IUCLID Cloud Service)
• ECHA's public e-learning offers
• ECHA's Cloud Service (notification in PCN format)

Transitional Provisions and PCN Process

Notifications of product mixtures must comply with Annex VIII in conjunction with Art. 45 of the CLP Regulation

using a gradual approach according to the respective use category:

Transitional provisions linked to the introduction of the PCN Format are shown in Figure 1 and will be explained in the following sections.

Figure 1: Overview of transitional provisions for the entry into force of the PCN procedure (for background on SDS transmission to ISi database, see below)

Transitional Provision According to National Legislation

According to the transitional regulation of the Chemicals Act § 28 para 12, notification for product mixtures intended for industrial use, i.e., for consumption exclusively in industrial settings at industrial sites (according to Regulation (EU) 2020/1677), may currently be submitted in an abridged form until 31 December 2023 (dark blue arrow in Figure 1).

For this purpose, an up-to-date safety data sheet (SDS) for the product is submitted in 'portable data format' (pdf) to the Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA). This kind of abridged product information is made available to Germany’s poisons centres via comprehensive access rights to the safety data sheets information system (ISi database).

Please note:

1. Submission of abridged notifications to the ISi Database does not apply to products subject to notification requirements according to the national Detergent and Cleaning Agents Act.
   Currently it is still possible, for detergent and cleaning products used exclusively at industrial sites, to abridge product notifications by submitting information according to Annex VII Section C of the European Regulation on Detergents Regulation (EU) 2020/1677. Further information is provided here.
2. Product notifications submitted to the ISi database purely in the form of safety data sheets do not fall within the scope of the EEA-wide transitional provisions of Annex VIII (until 1 January 2025). In order to benefit from the transitional provisions, product notifications have to be made using the national XProductNotification Format before 1 January 2024 (see following chapter). Guidance on how to submit notifications in the XProductNotification Format is provided in the FAQ on product notifications. Alternatively, notifications may be submitted in the new PCN Format as well.
3. The national transitional provisions according to § 28 (12) Chemicals Act have not been valid for private and professional use products since 1 January 2021.

Transitional Provision According to Annex VIII

Under certain conditions, product notifications that have been sent to the BfR using national notification formats within the deadlines specified in Fig. 1 fall under the transitional regulation of Annex VIII Part A 1.4 and 1.5 of the CLP Regulation. In addition, the following is defined with regard to conventional national product notifications:

1. Product notifications submitted in the national format (XProductNotification Format in Germany) will remain valid until 31 December 2024. This requires that no upcoming product updates are issued which would trigger an updated notification to be submitted before that date (blue green arrows in Figure 1). As a consequence, notification of products intended to be sold after 1 January 2025 onwards must be submitted in PCN Format by that date (green arrows in Figure 1).
2. Initial notifications (initial submission of new products) as well as notification updates* must be submitted in PCN Format from the effective dates onwards (blue green arrows in Figure 1).
3. On 1 January 2025, notifications submitted in the national format (XProductNotification) for products classified as hazardous will expire. Notification for all products intended to be sold after this date must be submitted in PCN Format in due time (green arrows in Figure 1).

*Mandatory notification updates are defined in Part B Section 4.1 of Annex VIII to the CLP. Further information can be found in the Guidance on harmonised information relating to emergency health response - Annex VIII to CLP.

Please note: Product notifications for consumer products intended for private or professional use, and which have only been submitted as Safety Data Sheet (SDS) to the ISi Database, will not benefit from the transitional provisions of Annex VIII and thus, must be made available to the BfR in PCN Format after 1 January 2021.

Product notifications of mixtures used at industrial sites only, which have already been submitted and will be submitted as a SDS to the ISi Database until 31 December 2023, will not benefit from the transitional provisions of Annex VIII. These products must be submitted in PCN Format by 1 January 2024, at the latest.

Data Protection and Data Safety

All received product information is handled with the strictest confidence and is only used for the purpose stipulated in Art. 45 Para. 2 of the CLP Regulation or § 10 of the national Detergent and Cleaning Agents Act respectively. The BfR complies with the strict data security requirements of the European Chemicals Agency (ECHA Standard Security Requirements).

Adherence to this security standard was confirmed by an external audit on 18 September 2020.

Costs

Product notifications to the BfR are free of charge.

Information on Safety Datasheets (SDS)

The requirements regarding structure and content of Safety Data Sheets are laid down in Annex II of the Regulation (EC) No 1907/2006 (REACH). For enquiries regarding Safety Data Sheets and in particular emergency telephone numbers in Section 1.4 and for any other questions regarding the REACH Regulation, please contact the national Helpdesk REACH-CLP-Biocides hosted by the German Federal Institute for Occupational Safety and Health (BAuA).