PCN notification to Poison Control Centers: Software for Annex VIII CLP and UFI Code

Annex VIII of the CLP: Regulatory Framework

Regulation (EU) 2017/542 introduced Annex VIII to CLP Regulation (EC) 1272/2008, establishing harmonized requirements for the transmission of information on hazardous mixtures to bodies designated by Member States (poison centers). The aim is to provide poison centers with the information they need to respond effectively to health emergencies.

Application Deadlines

Annex VIII entered into force with different deadlines depending on the type of use:

• January 1, 2021 — Mixtures for consumer use
• January 1, 2021 — Mixtures for professional use
• January 1, 2024 — Mixtures for industrial use

From January 1, 2025, all notifications must be in the harmonized PCN format. Notifications made in previous national formats are no longer valid.

Who Must Notify

The notification obligation falls on the importer or downstream user who places the hazardous mixture on the market in a Member State. The notification must be made before the mixture is placed on the market in each country of destination.

Which Mixtures Must Be Notified

All mixtures classified as hazardous for the following are subject to notification:

• Health hazards — Acute toxicity, skin corrosion/irritation, eye damage, sensitization, specific target organ toxicity, aspiration hazard
• Physical hazards — Explosives, flammable gases, flammable aerosols, flammable liquids, flammable solids, self-reactive substances and mixtures, pyrophoric liquids, self-heating substances and mixtures, organic peroxides, corrosive to metals

Exemptions from notification: medicines, medical devices, cosmetics (subject to CPNP notification), foodstuffs, mixtures classified only for environmental hazards.

Mixtures for industrial use: these are not exempt from notification. However, they can benefit from limited submission (simplified notification), in which information on composition can be limited to what is already reported in the SDS (Section 3). Notification must still be made before the product is placed on the market.

Non-hazardous detergents: at the harmonized EU level (Annex VIII), notification is only required for mixtures classified as hazardous. However, some Member States—Italy, Germany, Greece, and Portugal—require by national law that detergents and cleaning products not classified as hazardous also be notified to poison control centers. It is essential to check the specific national requirements for each target market.

The UFI (Unique Formula Identifier) code

The UFI code is a central element of Annex VIII. It is a unique 16-character alphanumeric code (format: XXXX-XXXX-XXXX-XXXX) that unambiguously links a specific mixture composition to the corresponding PCN notification.

UFI Code Requirements

• Uniqueness — Each different composition requires a different UFI. A new UFI is required when the composition changes beyond the tolerances allowed in Table 4 of Annex VIII.
• Mandatory labeling — The UFI must be included on the label, in the supplemental information section. For mixtures that are not packaged or intended exclusively for industrial use, the code may be indicated only in the SDS (Section 1.1).
• Generation — The UFI is generated using the ECHA algorithm from a formulation number (0–268,435,455, assigned by the company) combined with the company's VAT number or, alternatively, with a company key that can be obtained free of charge from the ECHA UFI generator (for companies without a VAT number or that prefer not to use it).
• Permanence — A UFI assigned to a composition must remain valid as long as the mixture is on the market with that composition.

How kemXpro manages UFI codes

kemXpro integrates the ECHA-compliant UFI generator directly into formulation management:

• Automatic generation of the UFI when a formulation is created or modified
• Validation of the UFI format according to ECHA specifications
• Tracking of the UFI history for each formulation (which UFI was active in which period)
• Automatic insertion of the UFI in the label and SDS (Section 1)
• Management of shared UFI situations (same UFI for grouped compositions — group submission)

The PCN format and the ECHA portal

The PCN notification must be submitted via the ECHA PCN portal in a structured electronic format. The required format is based on IUCLID (International Uniform Chemical Information Database), the same standard used for REACH registrations.

Contents of the PCN notification

Each PCN notification must include:

• Product identification — Trade name, UFI code, use category (consumer, professional, industrial)
• Full composition — All components with chemical identity (CAS, EC, IUPAC), CLP classification, and concentration range
• Toxicological information — Acute toxicity data, hazard classification
• Mixture classification — Full CLP classification with H and GHS phrases
• Physical-chemical properties — Color, physical state, pH, viscosity (for consumer and professional use)
• Packaging data — Type and size of packaging
• Countries of entry — List of EU countries where the product is marketed

Group Submission

Annex VIII allows for group submissions: a single PCN notification for multiple mixtures with similar compositions. This is possible when the mixtures belong to the same use category and differ only in fragrance or color (components not classified as hazardous). kemXpro supports the creation and management of group submissions with shared or individual UFIs for each variant.

When to Update the Notification: Exemptions and Tolerances

Annex VIII provides concentration ranges that define when a change in composition requires or does not require an update to the PCN notification. If the new percentage of a component remains within the range declared in the original notification, it is not necessary to make a new notification.

The tolerance ranges provided for in Annex VIII (Part B, Table 4) provide for 6 concentration bands with increasing tolerances:

• > 25–100% — maximum variation ±20% of the declared value
• > 10–25% — maximum variation ±30% of the declared value
• > 5–10% — maximum variation ±40% of the declared value
• > 1–5% — maximum variation ±30% of the declared value
• > 0.1–1% — maximum variation ±20% of the declared value
• ≤ 0.1% — maximum variation ±10% of the declared value

The tolerance always refers to the concentration declared in the initial notification, not to that of the latest update. This prevents successive cumulative variations from circumventing the update requirement.

The notification must be updated when:

• The concentration of a component falls outside the declared range
• A component is added or removed
• The CLP classification of the mixture changes (health or physical hazards)
• The trade name of the product changes
• New toxicological information becomes available

How kemXpro automates PCN notification

Automatic Generation of the PCN XML File

kemXpro automatically generates the XML file in IUCLID/PCN format, ready for upload to the ECHA portal, based on the data already present in the system:

• The composition of the formulation is extracted from the kemXpro database with all the required chemical information (CAS, EC, classification, concentrations)
• The CLP classification is automatically calculated by the kemXpro classification engine
• The physical-chemical properties are populated from the formulation data
• The UFI code is generated and inserted automatically

Tracking the status of notifications

For each product and each destination country, kemXpro tracks:

• Notification status — Draft, ready for upload, sent, accepted, rejected
• Submission number — ECHA reference number of the notification
• Need for update — The system alerts you when a change in composition or classification requires the PCN notification to be updated
• Notification history — Complete audit trail of all submitted versions

Multi-country management

Annex VIII requires notification to be made for each EU country where the mixture is marketed. kemXpro simplifies multi-country management:

• Generation of PCN notifications for all EU countries in a single operation
• Management of label language variants for each market
• Tracking of notification status country by country
• Management of complementary national regulations (some countries require additional information)