CLP EUH208 sensitiser statement

EUH208 on a CLP label: Contains (name of sensitising substance). May produce an allergic reaction.

Direct answer. For a mixture that is not classified as sensitising but contains at least one substance classified as sensitising, at a concentration equal to or greater than that specified in Table 3.4.6 of Annex I, Annex II section 2.8 of Regulation (EC) No 1272/2008 says the label shall bear: EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction.’ That supplemental statement is the one people look for on mixtures such as candles, wax melts, and fragrance oils. Read section 2.8 on the consolidated text at EUR-Lex. This page does not restate the numeric rows of Table 3.4.6. This page is not legal advice.

CLPLens: CLP Hazard Display (Shopify App Store · Write a review) shows hazard pictograms and statements you enter on the product page. It does not classify a mixture or decide that EUH208 applies. This page is the EUH208 supplemental statement — not the full Article 17 checklist and not candle classification.

Related: Prop 65 Warning Manager — Prop 65 warning with a chemical name on 2028 product pages.

Free check first: CLP label element checker runs in your browser and sends nothing. Paste CLP label text and see which Article 17 label elements it mentions or lacks.

The Annex II wording

Section 2.8 was substituted by Commission Regulation (EU) No 286/2011. As that section is carried in the regulation, the label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising, present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I, shall bear EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction.’

The same section says mixtures classified as sensitising that contain other sensitising substances (in addition to the one that leads to the classification), at or above the concentration specified in that table, shall bear the name or names of those other substances on the label.

Commission Regulation (EU) 2016/918 added that where a mixture is labelled in accordance with section 2.4 or 2.5, the statement EUH208 may be omitted from the label for the substance concerned. Sections 2.4 and 2.5 are the statements for mixtures containing isocyanates (EUH204) and epoxy constituents (EUH205). Confirm the live consolidated article before you omit EUH208.

The concentration trigger written in section 2.8 is “equal to or greater than that specified in Table 3.4.6 of Annex I.” The percentages live in that table on EUR-Lex. This page does not copy them, because a paraphrase of the table is easy to confuse with other Annex II thresholds, such as the EUH210 concentration lines in section 2.10.

ECHA’s page on deciding classification and labelling says supplemental EUH statements come from Annex II, and gives sensitising substances (EUH208) as a case where a mixture may still need Annex II labelling even if it is not classified as hazardous. Confirm that sentence on the live ECHA page.

Regulation (EU) 2024/2865, only as EUR-Lex states it

Regulation (EU) 2024/2865 amends Regulation (EC) No 1272/2008, including Annex II. Article 2 says Annex II applies from 1 July 2026, together with listed points of Article 1 and of Annex I. It also sets a derogation under which substances and mixtures may, until 30 June 2026, be classified, labelled, and packaged in line with specified provisions as they stood on 9 December 2024, including Parts 3 and 5 of Annex II. Recital 11 says the additional hazard statements in Part 2 of Annex II should apply to all mixtures referred to in that Part, whether or not they are classified and whether or not they contain a classified substance. The Annex II amendments in the published text of Regulation (EU) 2024/2865, as retrieved for this page, add refill-station rules and replace Part 5; they do not show a replacement of the EUH208 sentence in section 2.8. Article 1 also replaces the first subparagraph of Article 25(6) so that the special labelling rules in Part 2 of Annex II apply to mixtures containing substances referred to in that Part. Which of those amendments share the 1 July 2026 date is set out article by article in Article 2. Confirm the consolidated EUR-Lex text before you treat the 2024 revision as having changed EUH208.

A structural CLP label example

Elements only. Nothing below is a real product, a real substance, or a concentration. The Article 17 set is explained on the CLP label elements checklist. ECHA’s labelling page lists supplier details, nominal quantity for packages made available to the general public, product identifiers, and, where applicable, pictograms, signal word, hazard statements, precautionary statements, and supplemental information. ECHA also states an EU-established supplier as of 1 July 2026; confirm that date on the live ECHA page and on EUR-Lex.

Whether a candle, wax melt, or fragrance oil is a mixture that must carry EUH208 depends on its classification and on Table 3.4.6. Classification of those goods is CLP labels for candles and wax melts. This page does not classify them.

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What this page is not

Related pages

Not legal advice. Confirm Annex II section 2.8, Table 3.4.6 of Annex I, and Regulation (EU) 2024/2865 on EUR-Lex, and the ECHA labelling pages, before you treat EUH208 as required on a label. The app displays hazard content you enter; it does not classify the mixture.