The EU’s Classification, Labelling and Packaging Regulation, better known as the CLP Regulation, requires anyone placing a chemical substance or mixture on the EU market to identify its hazards against set criteria, communicate those hazards through a standardized label, package the product safely, and notify the European Chemicals Agency (ECHA) and national poison centres before it reaches customers. It is Regulation (EC) No 1272/2008, in force since 2009, and it implements the United Nations Globally Harmonized System (GHS) inside the EU so that hazard information reads the same way across borders.1European Agency for Safety and Health at Work. Regulation (EC) No 1272/2008 – Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Who Has to Comply
Any company that manufactures a chemical substance or mixture in the EU, or imports one into it, must classify, label, and package that product under CLP before placing it on the market.2European Commission. Classification, Labelling and Packaging of Chemicals The obligation is not limited to hazardous products; the assessment itself is universal, and the labeling and packaging duties kick in once a hazard is identified.
CLP works alongside the REACH Regulation (EC No 1907/2006). REACH handles registration, evaluation, and authorization across a chemical’s lifecycle; CLP handles hazard communication. Most substances have to satisfy both before they can legally reach the market.
Classifying a Substance or Mixture
Classification is the foundation. Before a label can be printed or a notification filed, you have to evaluate the product against three families of hazards: physical (flammability, explosivity), health (skin corrosion, carcinogenicity, respiratory sensitization, and others), and environmental (particularly aquatic toxicity).3European Commission. Classification and Labelling (CLP/GHS) – Section: Hazard Identification and Classification Each family contains multiple hazard classes, and each class has severity categories that determine which label elements you owe.
Self-Classification and Harmonised Classification
Most of the work sits with the company. Self-classification means gathering the available data on the substance, comparing it against the criteria in Annex I, and assigning the hazard classes yourself. This applies to all mixtures and to any substance that lacks an EU-level classification.
For particularly dangerous substances, the EU sets a harmonised classification in Annex VI. Those entries are legally binding: every supplier of that substance must apply the classification listed for the covered hazard classes, and self-classify for anything else. Check Annex VI first before doing any of the analytical work yourself, because if the answer is already there, you are required to use it.
Concentration Limits, Cut-Off Values, and M-Factors
Mixtures bring in thresholds. Articles 10 and 11 use specific concentration limits to set the percentage at which a hazardous ingredient triggers a given classification for the whole mixture, and cut-off values to set the floor below which an ingredient can be ignored entirely.4ReachOnline. CLP Annex I 1.1.2 – Specific Concentration Limits, M-Factors and Generic Cut-Off Values
Aquatic hazards add a further layer. Multiplying factors, or M-factors, apply to substances so acutely toxic to aquatic life that the standard concentration limits would understate the risk. A component with an acute aquatic toxicity value between 0.01 and 0.1 mg/l gets an M-factor of 10, meaning its concentration counts as ten times its actual percentage in the mixture calculation.5ReachOnline. CLP Annex I 4.1.3 – Classification Criteria for Mixtures Missing an M-factor is a common route to under-classifying a mixture.
What Must Appear on the Label
Once the classification is set, CLP prescribes what the label looks like. The elements are fixed so that the same visual and coded information reaches a worker in Portugal and a warehouse manager in Finland.
Pictograms and Signal Words
Hazard pictograms are diamond-shaped, red-bordered symbols with a white background and a black image indicating the hazard type: a flame for flammable substances, a skull and crossbones for acute toxicity, an exclamation mark for less severe hazards.6Occupational Safety and Health Administration. Hazard Communication Standard Pictogram The label carries a single signal word: “Danger” for more severe categories, “Warning” for less severe ones. Where both would apply, only “Danger” appears.7ReachOnline. CLP Article 20 – Signal Words
Hazard, Precautionary, and Supplemental Statements
Hazard statements (H-codes) describe each hazard in a fixed short phrase. H314, for instance, means the substance causes severe skin burns and eye damage. Precautionary statements (P-codes) tell the user what to do: P210 instructs the user to keep the substance away from heat, sparks, and open flames. Both are assigned by the regulation, not written by the manufacturer, so the wording on the label must match what CLP prescribes.
The EU adds its own supplemental statements (EUH codes) for hazards not fully covered by the international GHS. EUH001 (“Explosive when dry”), EUH014 (“Reacts violently with water”), and EUH066 (skin dryness from repeated exposure) have existed since CLP’s adoption. The 2023 revision added new EUH codes tied to the new hazard classes, including EUH380 (“May cause endocrine disruption in humans”) and EUH440 (“Accumulates in the environment and living organisms including in humans”). These sit on the label alongside the H-codes.
Labels must appear in the official language of every EU member state where the product is sold. New legibility rules apply from 1 January 2027: minimum font sizes tied to packaging volume, sans-serif typefaces, black text on white backgrounds, and line spacing of at least 120% of the font size.
The Unique Formula Identifier
Hazardous mixtures supplied to consumers and professional users have needed a Unique Formula Identifier (UFI) on the label since January 2021. The UFI is a 16-character alphanumeric code derived from the mixture’s formulation number and the company’s VAT number, and it creates a direct link between the physical product and the composition data held by national poison centres. Industrial-use mixtures have carried the same obligation since January 2024, and mixtures already on the market before those dates needed the code added by January 2025. The UFI usually sits near the barcode or the pictograms.
Packaging Duties
Packaging under CLP has to prevent leakage in normal handling, resist degradation from the contents, and hold up through repeated opening and closing. Two consumer-facing duties get most of the attention.
Products sold to the general public that meet certain hazard thresholds must have child-resistant fastenings, typically a closure requiring two coordinated movements such as pressing down while turning.8European Chemicals Agency. Child-Resistant Fastening and Tactile Warnings Products posing severe health risks, corrosives among them, also require a tactile warning: a raised equilateral triangle that allows a visually impaired person to identify the danger by touch. Where the packaging is too small for the triangle, three raised dots are allowed instead.
Small or awkwardly shaped containers get some relief under Article 29. Where standard labeling physically cannot fit, reduced labeling is permitted under Annex I section 1.5.1, with a further reduction under section 1.5.2 where even that will not fit.9Legislation.gov.uk. Regulation (EC) No 1272/2008 – Article 29 There is no set millilitre threshold; the test is physical impossibility.
The Two Notifications You Owe
Classification and Labelling Notification to ECHA
Every manufacturer or importer placing a classified substance on the EU market must notify ECHA of its classification and labeling within one month of first placing the substance on the market.10European Chemicals Agency. How to Notify Substances to the Classification and Labelling Inventory The notification identifies the notifier (legal name, address, and responsible contact), the substance (using standard identifiers such as CAS or EC numbers), the full classification, and the corresponding label elements. Submissions go through ECHA’s REACH-IT portal using IUCLID dossiers, and a successful submission generates a tracking number that serves as proof. From 2026, ECHA will begin publishing the names of notifying companies, though a confidentiality request can be made before 30 June 2026 where the notifier can show a commercial risk.
Poison Centre Notifications Under Annex VIII
Separately, companies placing hazardous mixtures on the market must submit Poison Centre Notifications (PCNs) to the relevant national appointed bodies. Annex VIII, adopted in 2017 and phased in over several years, requires detailed composition information so that poison centres can give accurate medical advice in an emergency. The phase-in deadlines were:
- 1 January 2021: mixtures for consumer and professional use
- 1 January 2024: mixtures for industrial use
- 1 January 2025: mixtures already on the market that had previously been notified under older national rules
Each PCN includes the UFI printed on the product label, tying the container in someone’s hand to the composition data on file. When a formulation changes, whether you have to update depends on how far concentrations shift. For components declared at exact concentrations, a component present at more than 25% can move by up to ±5% without triggering an update, while a component present at 2.5% or less can move by up to ±30%.11European Chemicals Agency. Changes in Composition and the Effect on the UFI Go beyond those tolerances and you need a new UFI and an updated PCN.
New Hazard Classes From the 2023 Revision
Delegated Regulation (EU) 2023/707 added hazard classes to CLP that did not previously exist in the regulation or in the GHS:
- Endocrine disruptors for human health, in Category 1 (known) or Category 2 (suspected)
- Endocrine disruptors for the environment
- PBT (persistent, bioaccumulative, and toxic) and vPvB (very persistent and very bioaccumulative) substances
- PMT (persistent, mobile, and toxic) and vPvM (very persistent and very mobile) substances, of particular concern for water resources
The compliance dates are staggered. From 1 May 2025, suppliers must assess substances against the new criteria and label accordingly. An 18-month transition to 1 November 2026 applies only to substances already produced, packaged, and labeled before May 2025. For mixtures, the corresponding date is 1 May 2026, with a transition running to 1 May 2028 for mixtures placed on the market before that date. Portfolio reviews against these classes cannot wait much longer.
What Happens if You Don’t Comply
Article 47 leaves penalties to each member state, requiring only that they be “effective, proportionate and dissuasive.”12ReachOnline. CLP Article 47 – Penalties for Non-Compliance There is no EU-wide fine schedule. Penalty ranges, inspection practices, and enforcement culture differ between Germany, Spain, Poland, and every other member state, so the consequences for the same failure can look very different depending on where the product is sold.
The common triggers for enforcement action are missing or incorrect label elements, failure to notify ECHA within the one-month window, packaging that does not meet child-resistant or tactile warning duties, and missed Annex VIII PCN deadlines. National inspectors can impose administrative fines, order products withdrawn from the market, or refer serious cases for criminal prosecution. For a company selling across several member states, a failure spotted in one country tends to draw attention from the others.