The UFI (Unique Formula Identifier) is a 16-digit code that must be included on the product label and in the safety data sheet. It enables poison centers to immediately identify the exact formulation of a product in an emergency.

The UFI ensures faster and more accurate medical care, as doctors and emergency centers can directly access the stored information. Companies must create the UFI for each product with hazardous ingredients and submit it to ECHA as part of the PCN notification.

The harmonized product notification is a legal obligation in the EU that ensures that toxic or hazardous chemicals are reported uniformly to the national poison centers. This regulation is based on the CLP Regulation (Classification, Labeling and Packaging) and is intended to enable rapid and targeted medical treatment in an emergency.

Once Annex VIII of the CLP Regulation came into force, the existing national notifications were replaced. A harmonized, electronic format for data transmission was implemented. Since 2021, all product notification information transmitted to the ECHA or the national poison information centers must comply with the XML format defined by the ECHA.

A product may not be sold in the EU without correct notification. The authorities can impose penalties or prohibit distribution in the event of non-compliance. Companies must therefore ensure that their product notifications comply with the requirements.

The obligation to notify lies with the so-called “distributor” of a product. This can be

• Manufacturers within the EU
• Importers who import chemicals from non-EU countries

Does the obligation to notify also apply to distributors?

Distributors who merely resell a product without modifying it, repackaging it or offering it under their own brand generally do not have to submit a notification.

However, distributors who sell a product under their own brand (even if they do not manufacture it themselves) must submit their own notification.

It must also be ensured that the notifiable product is notified in the EU country in which it is placed on the market. For example, if the intention is to sell a trade product in Italy, while the manufacturer or supplier has only notified in Germany, the distributor must carry out a separate notification for Italy. Communication with the supplier and along the supply chain is key.

A “mixture-in-mixture” (MiM) exists when a product itself contains a mixture that in turn consists of several components and has already been previously notified.

Since many chemical products are based on precursors, it is not always possible to disclose all ingredients directly. In such cases, the supplier of the MiM can provide a separate UFI reference.This enables the notification without having to provide the exact ingredients.

Yes, the product notification data is treated as strictly confidential. This confidentiality obligation arises from Article 45 of CLP Regulation (EC) No 1272/2008 and Article 9 of Regulation (EU) 2017/542, which introduced harmonized product reporting.

The reported information is made available exclusively to the national poison information centers and the competent authorities and may only be used for emergency measures, in particular for medical treatment in the event of poisoning. Disclosure to third parties or publication of the complete composition is not permitted.

Furthermore, companies can use protective measures such as the “mixture-in-mixture” (MiM) approach to protect confidential formulations from their suppliers without violating the reporting obligation. This ensures the protection of trade secrets while complying with legal requirements.

A PCN contains detailed information about the product, including

• UFI code for unique identification
• Chemical formulation, including hazardous ingredients
• Toxicological data to enable the correct treatment in an emergency
• Product category (EuPCS) for classification by intended use
• Physico-chemical properties such as pH value or viscosity
• Packaging information to help the emergency services make the correct assessment

The notification can only be completed successfully with complete and correct information.

The notification of products in accordance with the CLP Regulation is complex and requires technical knowledge and experience with the ECHA systems.

An external service provider offers the following advantages:

• Error minimization through expertise and standardized processes
• Time savings, as internal resources are not burdened
• Faster time to market as the notification is efficient and correct
• Individual support to meet specific company requirements

With our expertise, we support companies in meeting their compliance requirements smoothly - reliably, efficiently and individually tailored.