Summary

When hazardous mixtures enter the EU market, document review cannot stop at checking whether an SDS has been provided or whether a UFI appears on the label. The key issue is whether the product formulation, hazard classification, trade name, SDS, label, UFI, Poison Centre Notification (PCN), and target Member States remain consistent with one another.

A UFI is only a formula identifier and does not mean that a PCN has been completed. An SDS is a supply-chain hazard communication document and cannot replace a poison centre notification. From 1 January 2025, existing hazardous mixtures within the applicable scope were also required to transition to the harmonised notification format. The revised CLP requirements apply in stages from 2026 to 2028, so document review must also consider product use, the EU-established supplier, distribution arrangements, and the timing of market placement.

Which Hazardous Mixtures Require UFI and PCN Review?

The notification obligations under CLP Annex VIII mainly apply to mixtures placed on the EU market that are classified as hazardous on the basis of health or physical hazards.

Common duty holders include:

• Importers bringing hazardous mixtures into the EU;
• Downstream users formulating, reformulating, or placing mixtures on the market within the EU;
• Distributors that may assume additional obligations in certain cases involving cross-border distribution between Member States, renaming, or relabelling.

Mixtures classified only for environmental hazards are generally outside the main scope of Annex VIII poison centre notification obligations. Radioactive mixtures, mixtures under customs supervision that are not being treated or processed, certain mixtures used for scientific research and development, and some products governed by other specific legislation may also be subject to exemptions or different rules, depending on the product and its intended use.

Scope determination should answer at least the following questions:

1. Is the product a substance or a mixture?
2. Is the mixture classified for health or physical hazards?
3. Is the final use intended for consumers, professional users, or industrial-site use?
4. In which EU Member States will the product be placed on the market?
5. Who acts as the importer, downstream user, or supplier established in the EU?
6. Will the trade name, label language, or packaging change between markets?
7. Will a distributor sell across Member States, rename the product, or relabel it?

What Problems Do CLP, UFI, PCN, and SDS Each Address?

CLP

CLP is the EU regulatory framework for the classification, labelling, and packaging of substances and mixtures. It determines which classification and label elements must be used for hazardous mixtures and defines the corresponding responsibilities of different operators in the supply chain.

From 1 July 2026, the first group of provisions under the revised CLP begins to apply. These include the requirement that a substance or mixture must not be placed on the EU market unless there is a supplier established in the EU, identified on the label, who fulfils the relevant CLP obligations for that product. A non-EU manufacturer may provide technical documentation but cannot replace the responsibilities of the EU-established supplier.

UFI

UFI stands for Unique Formula Identifier. It is a 16-character alphanumeric code.

The UFI links a specific marketed product to the notified composition information for the mixture. The same composition may be marketed under multiple trade names or packaging sizes and use the same UFI. Mixtures with different compositions cannot share one UFI merely for convenience.

PCN

PCN stands for Poison Centre Notification. It is the submission of hazardous mixture information to the appointed bodies of Member States in accordance with CLP Annex VIII.

The notification information generally includes:

• The full trade name;
• The UFI;
• The mixture composition and concentrations or concentration ranges;
• Health and physical hazard classifications;
• Label elements;
• Toxicological information;
• Product use categories;
• Colour, physical state, and, where applicable, pH;
• Packaging type and size for consumer or professional-use products;
• Submitter and contact information.

PCNs are submitted using a harmonised electronic format. An SDS can provide a basis for classification, toxicological information, and some composition data, but it cannot directly replace a PCN.

CLP and PCN Implementation Timeline from 2025 to 2028

Regulation (EU) 2025/2439 postponed only certain requirements relating to label format, relabelling, advertising, distance sales, and refill stations. It did not postpone all revised provisions to 2028. The other application dates in 2026 and 2027 must still be addressed separately.

Four-Layer Information Consistency Review

Hazardous mixture document review can be divided into four layers.

Layer 1: Product and Formula Identity

The following information needs to be confirmed:

• Full trade name;
• Brand and product model;
• Internal product code;
• Formula number;
• Formula version;
• UFI;
• Whether samples and commercial batches use the same composition.

Using different product names in orders, SDSs, labels, and PCNs weakens document traceability. Even when the difference is only an abbreviation, language version, or brand variation, it is still necessary to confirm whether the relevant names have been included in the notification.

Layer 2: Basis for Hazard Classification

The following points need to be confirmed:

• Whether the classification is based on the current formulation;
• Whether the identities of hazardous ingredients are correct;
• Whether concentrations or concentration ranges support the current classification;
• Whether specific concentration limits, M-factors, or acute toxicity estimates apply;
• Whether classification has been reassessed after changes to the formulation, raw materials, or impurities.

An unchanged quality specification does not necessarily mean that the hazard classification is unchanged. After changing a raw material source, the content, colour, viscosity, and water level may still meet specification, while hazardous ingredients, impurities, or the composition of a mixture in mixture may have changed.

Layer 3: Supply-Chain Documents

The following documents should be compared horizontally:

• SDS;
• CLP label;
• Product specification;
• Batch COA;
• Packaging and transport information;
• Hazard information shown on product webpages or in electronic catalogues.

These documents should use the same product identity, classification outcome, and version basis.A broader review of COAs, TDSs, SDSs, and impurity profiles can help determine whether the supplier’s quality and safety documents describe the same commercial product.

Layer 4: Market Notification

The following points need to be confirmed:

• Whether the UFI corresponds to the current formulation;
• Whether the PCN has been submitted;
• Whether the notification covers the Member States where the product is actually sold;
• Whether all trade names have been included;
• Whether the use category is consistent with the actual sales channel;
• Whether packaging and product information still match the notified information.

CLP, UFI, and PCN Document Review Checklist

Product Identity and Hazard Classification

UFI and PCN Status

Cross-Checking the SDS and Label

Why Having a UFI Does Not Mean That a PCN Has Been Completed

A UFI can be generated before the PCN is submitted. Therefore, seeing a UFI on the supplier’s label is not sufficient to prove that the product meets the relevant notification requirements.

Using a UFI on a marketed product before the relevant notification has been submitted is inconsistent with the basic logic of Annex VIII because poison centres would be unable to link the code to the relevant mixture information.

When a supplier states that a product “already has a UFI,” the following points still need to be confirmed:

1. Which formulation and version does the UFI correspond to?
2. Which EU legal entity submitted the PCN?
3. Does the submission cover the target Member States?
4. Does it include the actual trade name?
5. Has the submitted information been updated after formulation changes?

The Four Most Important SDS Sections to Review

Section 1: Product Identity, Use, and Supplier

Section 1 determines which marketed product the SDS actually covers.

Key points include:

• Whether the product name matches the label;
• Whether the recommended use matches the actual sales scenario;
• Whether an appropriate EU supplier is identified;
• Whether emergency contact information is valid;
• Whether the UFI is shown in Section 1.1, where applicable.

For hazardous mixtures used only at industrial sites, the UFI may, under the applicable conditions, be shown in the SDS rather than being printed on the product label. Corresponding UFI display rules also apply to unpackaged mixtures.

Section 2: Classification and Label Elements

Section 2 needs to remain consistent with the actual label and PCN, including:

• Hazard classes and categories;
• Hazard pictograms;
• Signal word;
• Hazard statements;
• Precautionary statements;
• Supplemental hazard information.

If the SDS has been updated with a new classification while the label still uses old hazard statements, the documents may come from different versions.

Section 3: Hazardous Ingredient Information

SDS Section 3 generally lists hazardous ingredients that meet the applicable disclosure criteria, but it is not the same as a complete formulation and is usually insufficient on its own for reviewing PCN composition information.

The following points need to be confirmed:

• Whether the chemical names are accurate;
• Whether CAS numbers and EC numbers correspond to the stated names;
• Whether the concentration ranges explain the mixture classification;
• Whether any ingredient contributing to classification has not been adequately addressed;
• Whether impurities, stabilisers, or additives in raw materials may affect classification;
• Whether mixtures in mixtures can be traced through their names, composition information, or UFIs.

Where a supplier is unwilling to disclose the full formulation to a commercial partner for reasons of confidentiality, an information pathway must still be established to enable the EU importer or other relevant submitting entity to fulfil its notification obligations.

Section 11: Toxicological Information

The toxicological information required for a PCN is closely related to SDS Section 11.

Key points include:

• Likely routes of exposure;
• Acute and delayed symptoms;
• Skin, eye, inhalation, and ingestion effects;
• Sensitisation;
• Specific target organ effects;
• Aspiration hazard;
• Whether the information is consistent with the classification in Section 2.

Where a product has a clear health hazard classification but Section 11 contains only a general statement such as “no data available,” the basis for the classification and toxicological information usually requires further confirmation.

Limited Notification for Industrial Use Does Not Mean Exemption from PCN

A hazardous mixture used only at an industrial site may, under the applicable conditions, use a limited notification. A limited notification allows the composition information to be based mainly on the content provided in the SDS, but it does not mean that a PCN is unnecessary.

When a limited notification is used, contact details must also be provided for rapid access to more detailed product information, including a contact person, telephone number, and email address. The telephone number must be available 24 hours a day, seven days a week, so that the appointed body of a Member State can obtain more complete composition information in an emergency.

Industrial-use review should confirm:

• Whether the product is genuinely used only at industrial sites;
• Whether it may be used by professional users outside industrial sites;
• Whether downstream products may enter consumer or professional-use channels;
• Whether a standard or limited notification has been used;
• Whether the 24-hour contact channel is genuinely available;
• Whether the UFI is shown in SDS Section 1.1 as required.

Where a product also has consumer, professional, or other uses, a limited notification cannot be selected solely because most customers are factories.

Which Document Updates Are Triggered by Formula and Market Changes?

Different changes do not have the same effects on the UFI, PCN, SDS, and label. The actual assessment depends on whether the original notification used exact concentrations or concentration ranges, the classification outcome, and the requirements of the target Member States.

Where an ingredient concentration exceeds the permitted variation in the original notification, or exceeds the concentration range used in the original submission, the notification must be updated and a new UFI generated.

How to Review Samples, Commercial Batches, and Raw Material Substitutions

Passing technical validation at the sample stage does not mean that the UFI and PCN can automatically be carried over to subsequent commercial batches.

Before bulk procurement, the following points need to be confirmed:

• Whether the sample and commercial product use the same formulation;
• Whether the sample number can be traced to the formal product code;
• Whether the sample SDS corresponds to the actual sample composition;
• Whether the raw material supplier changes for the commercial product;
• Whether raw material substitution changes hazardous ingredients, impurities, or MiM composition;
• Whether the commercial product continues to use the same trade name and UFI;
• Whether formulation changes remain within the ranges permitted by the original notification.

Batch consistency does not require every quality test result to be identical, but the product must remain within the relevant quality specification and notified composition ranges.

Stable content, water, density, viscosity, or colour results in a COA show only that these quality parameters are similar. They do not, on their own, prove that the hazardous composition and PCN information remain unchanged.

Reviewing Labels, Member States, and Distribution Arrangements

A clear market-placement list should be established when hazardous mixtures enter different EU Member States.

It should include at least:

• Target Member States;
• Label languages;
• Full trade names;
• Product use categories;
• Packaging sizes;
• EU-established supplier;
• PCN submitting entity;
• UFI;
• Whether distributors rename or relabel the product;
• Whether the product is sold through a website or other distance-sales channel.

From 1 January 2027, the revised provisions related to Article 45 begin to apply. Where a distributor further distributes a hazardous mixture into another Member State, or renames or relabels it, the distributor may assume the relevant submission obligations if it cannot demonstrate that the appointed body of the Member State has already received the same information from an importer or downstream user.

Certain new advertising and distance-sales requirements have been postponed until 1 January 2028. However, companies still need to avoid conflicting product names or hazard information across websites, electronic catalogues, labels, and SDSs.

Common Document Warning Signs

How to Determine Whether Supplier Documents Are Complete and Traceable

A large number of documents does not necessarily indicate strong review quality. A more effective comparison focuses on four points.Document findings should also be considered within a broader chemical sourcing risk management process covering supplier qualification, batch traceability, logistics, and document control.

Complete Information

The supplier can provide current versions of the SDS, label artwork, specification, batch COA, UFI, and appropriate PCN status information.

Consistent Documents

The product name, formula version, hazard classification, EU supplier, use, and target countries correspond with one another.

Traceable Data

The marketed trade name can be traced to the product code, formula version, SDS version, UFI, and PCN submission information.

Controlled Changes

When the formulation, raw material, classification, trade name, packaging, or countries of sale change, the supplier can explain which documents need to be updated and whether the UFI and PCN need to be reassessed.

ChemicalCell Document Coordination Support

ChemicalCell can assist in organising supplier document requirements according to the specific product, intended use, and target market, and can coordinate the confirmation of product identity, SDSs, specifications, batch documents, labels, packaging, and available UFI and formula identification information.

Final responsibility for hazard classification, labelling, PCN submission, and placement on the EU market remains with the relevant EU-established supplier, based on the actual formulation, supply-chain role, and sales arrangement.

FAQ

Which mixtures require a UFI and PCN?

The main scope covers mixtures placed on the EU market and classified as hazardous on the basis of health or physical hazards. Substances, non-hazardous mixtures, mixtures classified only for environmental hazards, and certain exempt products need to be assessed separately according to their legal identity and intended use.

Can an SDS replace a PCN?

No. An SDS communicates hazard information through the supply chain, while a PCN provides emergency health response information to the appointed bodies of Member States. An SDS may provide some of the underlying data, but it usually does not contain all of the composition and market information required for a PCN.

Does generating a UFI mean that the PCN has been completed?

No. A UFI may be generated before the PCN is submitted. It is still necessary to confirm whether the UFI has been used in a notification, whether the target Member States are covered, and whether the actual trade name is included in the submitted information.

Can the same UFI be used for several trade names?

Yes, provided that the products use the same mixture composition and that the relevant trade names have been correctly included in the notification. Products with different compositions cannot share the same UFI.

Which formulation changes may require a new UFI?

Adding or removing ingredients, exceeding the concentration ranges in the original notification, or changing an exact concentration beyond the ranges permitted under Annex VIII will generally require an updated notification and a new UFI. Changing only a trade name, packaging size, or country of sale does not normally create a new formulation, although market or notification information may still need to be updated.

Can an industrial-use mixture be exempted from PCN?

Not automatically. A mixture used only at an industrial site may use a limited notification under the applicable conditions, but it remains within the PCN system and requires contact details that allow detailed product information to be obtained rapidly at any time.

Document Request and RFQ Information

When requesting documents or submitting an enquiry for an EU hazardous mixture, the following information may be provided at the same time:

• Product name and actual use;
• Consumer, professional, or industrial-use category;
• Target EU Member States;
• Estimated purchase quantity and packaging size;
• Required SDS, label, UFI, or PCN information;
• Whether renaming, relabelling, or cross-border distribution between Member States is involved;
• Sample validation and bulk procurement plan.

Clear information on the intended use, Member States, packaging, and supply-chain role helps the supplier provide documents that match the actual market-placement arrangement, rather than a generic document package that cannot be used directly for import, distribution, or label confirmation.

To confirm available product specifications, SDSs, labels, UFI information, or supplier documentation for a target EU market, submit a chemical product enquiry with the intended use, Member States, quantity, and packaging requirements.