Product notification of hazardous mixtures to the Federal Institute for Risk Assessment (BfR) and the European Chemicals Agency (ECHA) - the new Annex VIII of the CLP Regulation, PCN notification

At REACh ChemConsult GmbH, we provide advice and training on PCN notification and perform this for our customers.

Are you a manufacturer, importer or supplier of hazardous mixtures?
The legal basis for product notification is Article 45 of the CLP Regulation (EC) No. 1272/2008, § 16e of the Chemicals Act, Article 9 of the Detergents Regulation and § 10 of the Detergents Act. The supplementary Poisons Information Ordinance regulates the requirements for these notifications. The PCN (Poison Centre Notification) is sent to the ECHA, as the Poison Centre Notification Portal is maintained there. Alternatively, the notification to BfR can be made on a transitional basis.
The new Annex VIII of the CLP Regulation, (Regulation (EU) 2017/542) on harmonised information for emergency health care provides the harmonised notification format for the transmission of dangerous mixtures to the competent authorities of the Member States. In Germany the BfR is the notified body for this purpose.
Regulation (EU) 2017/542 of 22 March 2017 and the delegated Regulation (EU) 2020/11 of 29 October 2019 amended the CLP Regulation, mainly in Annex VIII. The amendments apply from 1 January 2020. Among other things, there are new notification obligations, labelling obligations, information in the safety data sheet; creation of recipe identifier, etc.
Annex VIII requires the establishment of a unique formula identifier (UFI) which establishes a clear link between the mixture placed on the market and the information provided in response to requests for information in the event of a medical emergency. The allocation of a UFI is free of charge.
The UFI must be clearly visible, legible and indelible on the label of the hazardous mixture. By way of derogation, for hazardous mixtures for industrial use and for mixtures which are not packaged, the UFI may alternatively be indicated in the safety data sheet.
The notification obligations for importers and downstream users placing mixtures on the market in accordance with Annex VIII will enter into force gradually:

• for mixtures intended for consumer use, from 1 January 2021 (the date was recently postponed by one year by Regulation (EU) 2020/11 of 29 October 2019)
• for mixtures intended for professional use, from 1 January 2021
• for mixtures intended for industrial use, from 1 January 2024

Importers and downstream users who, prior to the applicability dates referred to above, have submitted information to a body designated in accordance with Article 45(1) concerning hazardous mixtures which do not comply with this Annex, shall not be obliged to comply with Annex VIII for those mixtures until 1 January 2025.
Importers and downstream users must comply with Annex VIII if any of the changes described in section 4.1 of Part B of Annex VIII occur before 1 January 2025 before placing this modified mixture on the market.
The notification requirements (e.g. electronic in XML format, official languages, etc.) are set out in Part A, Section 3 of Annex VIII of the CLP Regulation.
The national transitional provision of Section 28 (12) of the Chemicals Act, which is currently applicable to some products (mixtures) classified as hazardous and allows for reduced notification, is extended until the phased entry into force of Annex VIII of the CLP Regulation:

• for mixtures intended for consumer use until 31.12.2020
• for mixtures intended for professional use until 31.12.2020
• for mixtures intended for industrial use, 31.12.2023

We take over the electronic transmission to ECHA/ alternatively to BfR and support you in fulfilling your obligations. We are also happy to take care of the notifications to the relevant authorities in other EU countries before they are placed on the market.

For companies not established in the EU or EEA, we offer the service of PCN reporting as their EU Only Representative. We then transmit the information on its behalf and the importers are then exempt from reporting. Confidential composition information does not have to be disclosed to the customer/importer then.

Pleasecontact us for the submission of an offer.