CLP Regulation — Classification, Labelling and Packaging of

Are our chemical labels compliant — and what happens if an inspector finds they are not?

Any manufacturer, importer or downstream user placing a substance or mixture on the EU market must classify, label and package it under the CLP Regulation — non-compliance triggers Member-State penalties that must be effective, proportionate and dissuasive, and enforcement authorities can pull non-conforming products from the market [Art. 47].

Short Answer

Regulation (EC) No 1272/2008 (CLP) implements the UN Globally Harmonised System (GHS) in the EU and is the single framework for classifying hazards, designing labels and specifying packaging of chemical substances and mixtures [Art. 1]. Every supplier in the chain — manufacturer, importer, downstream user, distributor — bears obligations: the upstream actor classifies and the label must carry pictograms, signal words, hazard and precautionary statements in the official language(s) of the Member State of sale [Art. 17]. Classification is not a one-off exercise: any new scientific or technical information triggers a review obligation without undue delay [Art. 15]. All information used for classification and labelling must be retained for at least 10 years after the last supply [Art. 49].

Who is affected

Manufacturers, importers, downstream users and distributors of chemical substances or mixtures placed on the EU/EEA market. Producers and importers of certain articles containing substances or mixtures listed in Annex I section 2.1 are also covered [Art. 4(8)]. Exclusions apply to medicinal products, cosmetics, medical devices, food and feed in their finished-product state, radioactive substances, and goods in customs transit [Art. 1(2), Art. 1(5)].

Deadline

Fully applicable since 1 June 2015 for mixtures (substances since 1 December 2010). The obligation is permanent and ongoing: every new substance or mixture must be classified, labelled and notified to ECHA within 1 month of first placing on the market [Art. 40(1)]. Classification must be reviewed without undue delay whenever new hazard information becomes available [Art. 15].

Risk

Penalties are set at Member-State level and must be effective, proportionate and dissuasive [Art. 47]. In practice, national enforcement ranges from administrative fines (e.g. Germany: up to EUR 50,000 under ChemG § 26; France: up to EUR 75,000 and 1 year imprisonment under Code de l'environnement) to market withdrawal orders and criminal prosecution. Beyond fines, competent authorities may invoke the safeguard clause to provisionally restrict or ban a non-conforming substance or mixture posing serious risk [Art. 52].

Proof

Legal status

• In force
• as of 2026-04-18
• Consolidated version of 01/09/2025

Primary sources

• EUR-Lex — Full text
• ECHA — CLP — European Chemicals Agency

What to do now

Legal / DPO

•Verify that every substance and mixture placed on the market carries a classification decision documented per Articles 5-13 — missing or outdated classification files are the most frequent enforcement finding.
•Audit confidentiality requests under Art. 24: alternative chemical names on labels require ECHA approval with a fee and are only granted where disclosure would harm trade secrets — expired or unapproved requests expose the full IUPAC name obligation [Art. 18].
•Confirm that the 10-year record-keeping obligation under Art. 49 is met for every substance and mixture, including all test data, expert-judgement reasoning and classification decisions used.

Compliance

•Maintain a live register of all substances and mixtures with their current CLP classifications and review triggers — Art. 15 requires re-evaluation without undue delay whenever new scientific or technical information emerges.
•Ensure ECHA notification is filed within 1 month of first placing any classified substance on the market, and that updates are submitted whenever the classification changes [Art. 40].
•Cross-check that label elements — pictograms, signal words, hazard and precautionary statements — follow the precedence rules in Articles 26-28 and do not exceed 6 precautionary statements per Art. 22(1).

IT / Security

•Implement version-controlled storage for Safety Data Sheets and label artwork so that any classification update under Art. 15 triggers an automated relabelling workflow across all affected SKUs.
•Integrate ECHA's C&L Inventory API into the substance management system so that harmonised classification changes in Annex VI Part 3 are flagged automatically [Art. 42].
•Ensure the IT system enforces the mandatory label language rules — labels must appear in the official language(s) of each Member State of sale [Art. 17(2)] — and blocks shipment if the correct language version is missing.

Product / Engineering

•Design packaging to meet Art. 35 requirements: child-resistant fastening for substances/mixtures supplied to the general public with specific hazards (Annex II section 3.1) and tactile warning of danger (Annex II section 3.2).
•Verify that product advertisements mention the hazard class for every hazardous substance or mixture — Art. 48 requires hazard communication even in advertising material.
•For distance sales to the general public, ensure that the online product listing displays all hazard types shown on the label before the consumer completes the purchase [Art. 48(2)].

Key Terms

Hazard class: The nature of a physical, health or environmental hazard — e.g. flammable liquid, acute toxicity, aquatic hazard. Each class is subdivided into categories reflecting severity [Art. 2(1)].
Hazard category: A division within a hazard class that specifies the degree of severity. Category 1 is typically the most severe [Art. 2(2)].
Hazard pictogram: A standardised graphical composition — red-bordered diamond with a GHS symbol — affixed to the label to convey information about the specific type of hazard [Art. 2(3), Art. 19].
Signal word: A word on the label indicating the relative level of severity: 'Danger' for the more severe categories and 'Warning' for the less severe categories [Art. 2(4), Art. 20].
Placing on the market: Supplying or making available a substance or mixture to a third party, whether for payment or free of charge. Import counts as placing on the market [Art. 2(18)].
Downstream user: Any natural or legal person established in the EU, other than a manufacturer or importer, who uses a substance (on its own or in a mixture) in the course of industrial or professional activities [Art. 2(19)].
M-factor: A multiplying factor applied to the concentration of a substance classified as hazardous to the aquatic environment, used to derive the classification of a mixture by the summation method [Art. 2(34), Art. 10].
Cut-off value: A threshold concentration above which an identified impurity, additive or individual constituent must be taken into account for classification of the substance or mixture [Art. 2(31), Art. 11].

Frequently Asked Questions

Does the CLP Regulation apply to cosmetics, medicines or food?

No. Finished medicinal products, veterinary medicinal products, cosmetic products, medical devices, and food or feed are excluded from CLP when in their finished state intended for the final user [Art. 1(5)]. However, the raw chemical substances used to manufacture those products remain subject to CLP during supply.

How quickly must a label be updated after a classification change?

When a new classification results in a more severe hazard category, the label must be updated without undue delay. For other changes (e.g. addition of a new hazard or removal of one), the supplier has up to 18 months [Art. 30].

What is the difference between 'Danger' and 'Warning' signal words?

'Danger' is reserved for the more severe hazard categories and 'Warning' for less severe ones. Only one signal word may appear on a label — if both apply, 'Danger' takes precedence [Art. 20].

When must a substance be notified to ECHA?

A manufacturer or importer must notify ECHA within 1 month of first placing a classified substance on the market [Art. 40(1)]. The notification must include the substance identity, classification, label elements and, where applicable, specific concentration limits and M-factors with justification.

Can a downstream user rely on the supplier's classification?

Yes — provided the downstream user does not change the composition of the substance or mixture and the upstream classification was made in accordance with Title II [Art. 4(5)-(6)]. If the downstream user has reason to believe the classification is incorrect, they must carry out their own evaluation.

Are there special rules for small packages?

Yes. Art. 29 provides labelling exemptions for packages where the contents do not exceed certain volumes (typically 125 ml or less), allowing omission of some hazard or precautionary statements where the full label would be impractical. The details are set out in Annex I section 1.5.2.

What is harmonised classification and how does it differ from self-classification?

Harmonised classification is decided at EU level for substances with CMR (carcinogenic, mutagenic, reprotoxic) or respiratory sensitisation properties and is listed in Annex VI Part 3 — it is legally binding on all suppliers [Art. 36-37]. Self-classification is the supplier's own assessment for hazard classes not covered by a harmonised entry.

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