1. Regulatory Background

1.1 CLP Article 45 and Annex VIII

EU poison centres notification is from EU CLP Article 45. Appoint bodies in member states are responsible for receiving information relevant, in particular, for formulating preventative and curative measures, in particular in the event of emergency health response, from importers and downstream users placing mixtures on the market. Annex VIII defines relevant requirements for notifications in a harmonised format.

1.2 Purpose and Significance

The collected information on hazardous mixtures can be used to formulate preventative and curative measures, especially can cover the medical needs in emergency health response. Moreover, these information can also be used in statistical analysis to ensure where the risk control measures should be improved. The implementation modalities of CLP Article 45 vary among different member states. Importers have to submit several notifications according to different requirements from different appointed bodies if they placing products on several member states' markets. Annex VIII published in 2017 standardizes the content and the method of notifications. Duty holders can use ECHA submission portal to submit notifications in a harmonised format to various member states that placed the products, which makes the process of notification more simple and convenient.

2. Notification in Harmonised Format

2.1 Implementation Time

The implementation time for notifications in harmonised format are related to the end use of the mixture. End use refers to the use of mixtures at the end of the supply chain. The implementation time for mixtures for professional use and consumer use is on Jan 1, 2021 and for industrial use is on Jan 1, 2024. Before the relevant implementation time, the mixture continues to be subject to existing requirements of national regulation. Mixtures already notified under national legislation remain valid until January 1, 2025. If there is a change to the mixture before this date, such as changes in mixture components, toxicological properties or product identification, companies may need to submit notification in harmonised format.

Figure 2-1 Industrial use, professional use and consumer use

2.2 Implementation of Notification in Harmonised Format in Member States

As of August 2023, Bulgaria is still unable to use the ECHA submission portal to submit dossiers, and all other member states of European Economic Area (EEA) can make PCN in a harmonised format through the PCN portal.

3. Requirements for Notification

3.1 Duty Holders

Importers and downstream users placing certain hazardous mixtures on the market as responsible for the submission of the information to appointed bodies. EU-based duty holders cannot be replaced by non-EU suppliers.

Table 3-1 Duty holders

3.2 Voluntary Notification

Companies can make voluntary submission for mixtures that classified as environmental hazardous or non-hazardous. If mixtures classified as health and physical hazardous and are used as MIM (Mixture in mixture) to formulate other mixtures by downstream formulators, the supplier can make voluntary submission to protect its trade secrets.

Non-EU companies  
Ideally, the non-EU supplier of the hazardous mixture shall disclose the entire mixture formulation information to their customer (the EU importer), so that the latter can make their submission. 

Nevertheless, there are cases where complete information pursuant to Annex VIII is not available or not given because of confidentiality reasons, in that case EU importers could ask the non-EU supplier to make a voluntary submission via any EU-based Legal Entity to whom they are willing to provide the full information required by Annex VIII. The EU importers will then be able to refer to this submission where they get the UFI number for their own submission.

3.3 Objects Need to be Notified

Mixtures that are placed on the EU market and classified as hazardous based on their health or physical effects need to be notified. the product is a combination of article (used as a container or support material) and mixture, for instance, ink from printer cartridge and solution on wet cleaning wipes, it should be notified. The product can be placed on the market only when its notification has been submitted.

3.4 Exemptions

• Mixtures classified for environmental hazards only;

• Radioactive mixtures;

• Mixtures which are subject to customs supervision;

• Mixtures used in scientific research and development;

• Medicinal and veterinary medicinal products;

• Cosmetic products;

• Medical devices;

• Food or feeding stuffs;

• Mixtures classified for gases under pressure only; and

• Explosives.

3.5 Contents of Notification

Four parts of information listed below usually need to be submitted in a notification:

1. Submitter details: name, address, telephone number, e-mail, VAT number;

2. Product information: active markets, trade names, main intended use, end use type, package type and size

3. Mixture information: name, physical state, color, pH, 100% components, GHS classification and label elements, toxicological information; and

4. UFI.

Companies can provide SDS of the mixture to complete the information required for notification.

3.6 Update Submission

Update submission have to be made when GHS classification of health and physical changed, add new trade names, add new UFI or add new toxicological information. If only package or emergency number changed, companies can also make an update submission. Appointed bodies in member states can ask companies to explain some information and make an update submission.

4. Unique Formula Identifier (UFI)

4.1 What is UFI?

UFI is a unique 16-digit alphanumeric code that can establish an unequivocal link between the information provided in the notification and the corresponding product in the market. UFI will become effective only after notification.

A sample of UFI: YV9K-3J9A-G209-C2T7

4.2 Relationship Between UFI and Mixtures/Products

One mixture can have one or more UFI. Various mixtures cannot use the same UFI. Multiple products can use the same UFI if their mixture formulation is the same.

4.3 Placement of UFI

Revisions of SDS in Annex II of REACH were enforced from 2023. The regulation requires that mixtures should have their own UFI in accordance with the requirements from Annex VIII of CLP regulation, and add it on SDS section 1.1. Also, UFI have to be printed or pasted on its label or package of the product. Mixtures used only in industrial sites can just add their UFI on SDS section 1.1. The UFI must be added in SDS section 1.1 for products without packaging. There are no requirements of UFI placement for mixtures with voluntary submission.