Poison centre notification: who submits a hazardous mixture to EU poison centres, what it holds and when

The law is CLP, Regulation (EC) No 1272/2008Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027The whole regulationClick opens the law on the EU Publications Office., Art. 45Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45Click opens the article on EUR-Lex. and Annex VIII. Each EU country appoints a body to receive the information, often a poison centre (Art. 45(1)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1Click opens the article on EUR-Lex.). Until 31 December 2026 the duty to submit rests on Annex VIII, Part A, sections 2.1 and 3.1, in the wording of the consolidated text of 1 July 2026. From 1 January 2027 it sits in Art. 45(1b)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1bClick opens the article on EUR-Lex. and Art. 45(1c)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1cClick opens the article on EUR-Lex., in the revision of Regulation (EU) 2024/2865Regulation (EU) 2024/2865, amending the CLP Regulation (consolidated text of 23 December 2025)The whole regulationClick opens the law on the EU Publications Office. (Official Journal text, Art. 1Regulation (EU) 2024/2865, amending the CLP Regulation (consolidated text of 23 December 2025)Article 1Click opens the article on EUR-Lex., point (24)). A business may apply the 2027 wording already, until 31 December 2026 (Art. 2(5)Regulation (EU) 2024/2865, amending the CLP Regulation (consolidated text of 23 December 2025)Article 2, paragraph 5Click opens the article on EUR-Lex.).

Importers and downstream users submit, and distributors join on 1 January 2027

CLP’s duties fall on a “supplier”: a manufacturer, importer, downstream user or distributor that places a substance or a mixture on the market (Art. 2(26)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 26Click opens the article on EUR-Lex.). Importers, downstream users and distributors are each defined as established in the EU (Art. 2(17)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 17Click opens the article on EUR-Lex., Art. 2(19)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 19Click opens the article on EUR-Lex., Art. 2(20)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 20Click opens the article on EUR-Lex.). Placing on the market means supplying or making available to a third party, paid or free, and import counts as placing on the market (Art. 2(18)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 18Click opens the article on EUR-Lex.).

The revision gives its reason in recital 32. Without a submission from distributors, the appointed bodies lose information when a mixture moves from one EU country to another, or when a distributor rebrands or relabels it. ECHA’s reading, of 10 December 2024: where no notification exists in a country where the mixture is placed on the market, or the label carries new product identifiers, the distributor either gives the information to the supplier or original notifier so that it can be added to that submission, or submits its own (ECHA, CLP revision defines new role for distributors).

ECHA adds that the duty of Article 45Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45Click opens the article on EUR-Lex. rests on importers and downstream users based in the European Economic Area: the EU countries and Norway, Iceland and Liechtenstein (ECHA, Questions and Answers, a text last updated on 26 October 2020 by its own note).

Which mixtures need a poison centre notification

The duty covers mixtures “classified as hazardous on the basis of their health or physical effects” (Art. 45(1b)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1bClick opens the article on EUR-Lex.; Annex VIII, Part A, section 3.1). A mixture is “a mixture or solution composed of two or more substances” (Art. 2(8)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 8Click opens the article on EUR-Lex.), so a blended diffuser oil, a cleaner, a paint or a glue can be one.

A kit of several mixtures is not one submission. ECHA’s answer is that each hazardous mixture in a multi-component product needs its own notification and UFI (ECHA, Questions and Answers).

A mixture that needs no submission may still be notified voluntarily. Belgium’s authority encourages it for non-classified mixtures (FPS Public Health). Which mixture is hazardous is decided by classification under CLP, which EU CLP Regulation sets out.

What the submission contains

Annex VIII, Part B, sets the contents. They are the same for every EU country, and they go in one structured file (Annex VIII, Part A, sections 3.1 and 3.4; Part B).

Which components are reported follows two limits. A component classified as hazardous for its health or physical effects is reported at 0.1% or more, and below that when it is identified, unless the submitter can show it is irrelevant for emergency health response. A component that is not classified as hazardous is reported when it is identified and present at 1% or more (Annex VIII, Part B, section 3.3).

Concentrations go in as exact percentages or as ranges. The tables of section 3.4 cap the width of a range:

The Annex also allows these shortcuts. A group submission covers several mixtures with the same classification for health and physical hazards, the same components and the same ranges, and it allows the mixtures to differ in their perfume if the differing perfumes total no more than 5% of each (Annex VIII, Part A, sections 4.1 to 4.3). Interchangeable component groups let you report one total for components that are used for the same function, with the same classification and toxicology (Part B, section 3.5). A mixture that follows a standard formula of Part D, which covers cement, gypsum binder and ready mixed concrete, may be submitted as that formula (Part B, section 3.6). A fuel on the list in Table 3 may be submitted from the safety data sheet (Part B, section 3.7). The generic names “perfumes” and “colouring agents” may stand for components used only to add scent or colour, if none is classified for a health hazard and the totals stay within 5% and 25% (Part B, section 3.2.3).

The appointed body may make a reasoned request for more information, and the submitter answers “without undue delay” (Annex VIII, Part A, section 3.2). The bodies guard the confidentiality of what they receive and may use it only to meet medical demand and, where an EU country, the Commission or ECHA asks, for statistics (Art. 45(2)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 2Click opens the article on EUR-Lex.).

ECHA’s portal sends one dossier to every country you choose

The law fixes the channel and leaves the tool open. The submission goes “by electronic means in an XML format provided by the Agency and made available free of charge” (Annex VIII, Part A, section 3.1). ECHA must specify, maintain and update the formats and make them available free of charge on its website (Annex VIII, Part A, section 6.1). ECHA does it with two tools.

• The ECHA Submission portal. ECHA describes it this way: “ECHA Cloud is an online service allowing EU-based companies to prepare and submit PCN dossiers in IUCLID format”. You create an ECHA Account, accept the terms and work in the Cloud, moving between IUCLID Cloud for preparing the dossier and the submission portal for sending it. The alternative is IUCLID 6 on a desktop or server, where you build the dossier offline and upload it later. The portal runs automated validation checks when you submit. A dossier that passes is made available to the appointed bodies, through an eDelivery service or the Poison Centre Notification Database. ECHA also runs a test environment, so you can try a submission without the bodies receiving test data (ECHA, Prepare and submit PCN).
• The system-to-system service. A company that builds the dossier in its own systems, in the PCN format, sends it to the portal through an automated transfer (ECHA, System-to-system service).

The PCN format is XML, compatible with IUCLID and published as XSD files. ECHA updates it every year with the IUCLID release. Its copy of the format page of 7 December 2024 lists version 6 of 18 July 2024, and ECHA’s home page of 14 May 2026 headlines version 8 of the format, released with IUCLID 6 version 10 on 29 April 2026 (ECHA, Poison Centres Notification format; ECHA, home page).

One dossier can reach several countries. ECHA’s answer: in principle you submit to the appointed body of every country where you place the mixture, in that country’s language, and the portal supports a multi-country submission by dispatching the notification to each body (ECHA, Questions and Answers). A consultant may submit on a duty holder’s behalf through the foreign user function of the ECHA Account. The duty holder stays liable for what is submitted (same source).

Countries decide the rest. ECHA’s page says that further information on national submission systems, fees, acceptance criteria and timelines “are at the discretion of each Member State”. ECHA keeps a country-by-country overview of these decisions. The latest version found, 13.0 of 1 September 2024 (Web Archive copy of 6 October 2024), says:

• Which system. Most countries listed took notifications only through the portal. Belgium, France, Germany, Latvia and Portugal took them through the portal or their own national system. Luxembourg’s notifications go to the Belgian appointed body. Only Bulgaria was marked as not yet ready to accept portal submissions. Earlier versions let several countries keep a national system open for industrial mixtures. Version 13.0 removed that note for Austria, Czech Republic, Ireland, Liechtenstein, Spain and Sweden. That national route is closed in any case: industrial mixtures have fallen under Annex VIII since 1 January 2024, and a submission in a non-harmonised national format stopped counting on 1 January 2025 (Annex VIII, Part A, sections 1.3 to 1.5).
• Which language. Many countries accept English as well as their own language. Others, such as Bulgaria, Czech Republic, Poland, Romania, Slovakia and Slovenia, want only their own.
• When you may sell. In most countries you may sell as soon as the portal’s automated checks pass. In Belgium, France, Germany, Italy, Luxembourg and Spain you wait for confirmation that the appointed body received the dossier.

ECHA calls these entries indicative and subject to change, and national rules have moved since. Belgium requires the notification at least 48 hours before the mixture is placed on the Belgian market, prefers the ECHA portal, accepts a direct notification valid for Belgium only, and asks you to use one system per product, because a double notification brings a double fee (FPS Public Health). Italy takes notifications of hazardous mixtures for consumer or professional use, and of detergents whatever their classification, only through the ECHA portal (ISS, Archivio Preparati Pericolosi).

From 1 January 2027 a country may appoint ECHA as its body (Art. 45(1a)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1aClick opens the article on EUR-Lex.). Recital 33 of the revision gives the reason: ECHA already runs a Union-level poison centres notification portal and a database, and can receive the information for countries that choose it. ECHA’s list of appointed bodies in its copy of 21 September 2025 names national bodies only (ECHA, National support).

A submission update is due when composition, classification or identifiers change

A submission does not expire. ECHA says the information must be up to date for as long as the mixture is placed on the market, and that a company that no longer places it on the market need not update it (ECHA, Questions and Answers). Annex VIII requires an update “without undue delay” when a trigger occurs, and before the changed mixture is placed on the market (Annex VIII, Part A, section 3.5; Part B, section 4.1).

Up to 31 December 2026 the triggers are these. From 1 January 2027 the last one is added.

• The product identifier or the UFI changes.
• The classification for health or physical hazards changes.
• New relevant toxicological information on the mixture or its components becomes available. It is the information that section 11 of the safety data sheet requires.
• The composition changes in one of three ways: a component that must be indicated is added, substituted or deleted; the concentration of a component moves beyond the range in the original submission; or an exact concentration moves by more than Table 4 allows.
• From 1 January 2027: any other change to a mixture on the market that is relevant for emergency health response (Annex VIII, Part B, section 4.1, with the fifth indent added by Regulation (EU) 2024/2865Regulation (EU) 2024/2865, amending the CLP Regulation (consolidated text of 23 December 2025)The whole regulationClick opens the law on the EU Publications Office., Annex IV, point (2)(e), as printed in the consolidated text of 1 January 2027). ECHA’s example: a change of packaging type, product category or contact details (ECHA, CLP revision defines new role for distributors).

(Annex VIII, Part B, section 4.1, Table 4.)

Two cases have their own rule. A mixture that follows a standard formula of Part D needs an update only when its composition stops conforming to the formula. A mixture whose composition is given from the safety data sheet needs one when section 3 of the safety data sheet is updated (Annex VIII, Part B, section 4.1). In a group submission, a change in the perfumes needs the list of mixtures and perfumes updated. The update is a revised version of the previous submission (Annex VIII, Part B, sections 4.1 and 4.2).

A change of composition beyond the limits also needs a new UFI, which is covered under “The UFI links the submission to the label”.

The deadlines depend on the use of the mixture

Annex VIII has applied in steps by use of the mixture, and the distributor duty comes last.

Mixtures for consumer use, professional use and industrial use are defined in Annex VIII, Part A, section 2.4: for example, a mixture for industrial use is one “intended to be used at industrial sites only”. Where a mixture has more than one use, the rules of every relevant use apply.

ECHA’s news of 1 October 2024 states the effect of the 2025 date. From 1 January 2025 a submission in a non-harmonised national format no longer complies with CLP. A company that wants to keep placing such a mixture on the market submits a new notification under Annex VIII and puts the UFI on the label (ECHA, news of 1 October 2024).

Fees depend on the country

ECHA charges nothing for the submission, and the portal has no invoicing function. Whether a country charges, and how much, is that country’s decision, and the money goes between the submitter and the national body (ECHA, Questions and Answers). ECHA’s overview of September 2024 marked fees in three countries only, Belgium, Hungary and Italy, and “No fees” for every other country it lists (ECHA, Overview of Member States decisions). The overview is older than Belgium’s 2026 fee, so the three authorities’ own pages follow.

No other country’s fee was read. ECHA’s overview calls its entries indicative, and no current country-by-country fee list from ECHA was found.

A non-EU supplier acts through its EU importer

CLP gives the submission duty to importers, downstream users and distributors, and defines each as established in the EU (Art. 2(17)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 17Click opens the article on EUR-Lex., Art. 2(19)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 19Click opens the article on EUR-Lex., Art. 2(20)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 20Click opens the article on EUR-Lex.). ECHA says the same: Article 45Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45Click opens the article on EUR-Lex. puts the duty on importers and downstream users based in the European Economic Area. Since 1 July 2026 a second rule points the same way: no substance or mixture may be placed on the market unless a supplier established in the EU, identified on the label, meets CLP for it (Art. 4(11)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 4, paragraph 11Click opens the article on EUR-Lex.). A business in the United States, the United Kingdom or China is not established in the EU, so it is not a submitter. The submitter is usually the EU importer that places the mixture on the EU market.

What that means for a supplier outside the EU:

• The importer needs your composition. ECHA’s answer is that importers need information on the composition of what they import to comply with CLP and REACH, and that the supply chain has to provide it (ECHA, Questions and Answers). The dossier asks for each component above the limits of Part B, section 3.3, with its concentration or range.
• A confidential composition. ECHA’s answer for a non-EU supplier that does not want to disclose its composition: the supplier may decide, in agreement with the EU importer, to make a voluntary submission through an EU-based legal entity and give the UFI to the importer. The importer then makes its own submission and refers to that UFI in the composition. ECHA says this protects the supplier’s confidential business information (ECHA, Questions and Answers). Annex VIII, Part B, section 3.2.2(a) allows a mixture inside another mixture to be named by its product identifier, concentration and UFI where the appointed body has already received that mixture’s submission.
• A blend you bought in. If your product contains a mixture whose full composition you do not have, your supplier’s UFI and the concentration can stand for it in the submission. Where the appointed body has not received the supplier’s own submission, the entry also carries the composition from the supplier’s safety data sheet and the supplier’s name, email address and telephone number (Annex VIII, Part B, section 3.2.2).
• A consultant. A consultant can submit for the duty holder through the foreign user function of the ECHA Account. The duty holder stays liable (ECHA, Questions and Answers).
• The label. The same EU supplier is the one named on the label under Art. 4(11)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 4, paragraph 11Click opens the article on EUR-Lex.. The importer’s role is set out in importer of record.

Whether the importer can use you as its foreign user is not stated. ECHA’s text names a consultant. The confidential route above is a separate matter: it uses a voluntary submission and a UFI, not the foreign user function.

The UFI links the submission to the label

The UFI code is the thread between the submission and the pack. The submitter creates it with the tool ECHA provides, free of charge, includes it in the submission, and prints it on the label as “UFI:” followed by the code (Annex VIII, Part A, sections 5.1 and 5.2; Part B, section 1.1). A change of composition beyond the limits of Part B, section 4.1 needs a new UFI, and one UFI never stands for two compositions. How to make the UFI code, where it goes on the label and when a new one is needed is covered in UFI code.

What happens if you do nothing

A mixture that does not comply with CLP may not be placed on the market (Art. 4(10)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 4, paragraph 10Click opens the article on EUR-Lex.). Each EU country keeps up official controls so that mixtures are not placed on the market unless “classified, labelled, notified and packaged” in line with CLP (Art. 46(1)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 46, paragraph 1Click opens the article on EUR-Lex.). Each country also sets its own penalties, which must be “effective, proportionate and dissuasive” (Art. 47Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 47Click opens the article on EUR-Lex.). What market surveillance and customs can do with a product that fails is in CLP label requirements.

Inspectors have looked for exactly this. ECHA’s home page reports that the pilot enforcement project of the ECHA Forum found that 19% of the hazardous mixtures checked had not been notified to poison centres (ECHA, home page).

What the law leaves open

• A distributor’s stock sold on after 1 January 2027. Art. 45(1c)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1cClick opens the article on EUR-Lex. applies from 1 January 2027 (Art. 2(3)Regulation (EU) 2024/2865, amending the CLP Regulation (consolidated text of 23 December 2025)Article 2, paragraph 3Click opens the article on EUR-Lex.) to distributors that “subsequently distribute” a mixture in other EU countries or rebrand or relabel it. No article says whether a mixture that a distributor already holds on that date is covered when it is later sold across a border.
• A distributor before 2027. ECHA’s Questions and Answers, last updated on 26 October 2020 by their own note, say that distributors, in particular rebranders and relabellers, may need to submit if the supplier’s submission does not hold the information, and that the role of rebranders had not been agreed among EU country authorities. From 1 January 2027 Art. 45(1c)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1cClick opens the article on EUR-Lex. decides the case.
• A non-EU seller shipping straight to a consumer, or importing its own stock. The submitter is an importer, downstream user or distributor established in the EU. No article names who submits for a parcel that goes from outside the EU straight to a consumer, the same gap as for the EU supplier (see what the law leaves open). The same gap opens when a non-EU seller brings its own stock into the EU, for example into a fulfilment warehouse, through an indirect customs representative: CLP’s importer is an EU-established person “responsible for import” (Art. 2(17)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 2, point 17Click opens the article on EUR-Lex.), and no article says whether the representative or any other EU party is that person, or who submits if none is. Meanwhile, sell a hazardous mixture into the EU through an EU business that submits it.
• Whether a non-EU supplier can be the foreign user of its own importer. ECHA’s text names a consultant. No text read says whether a supplier outside the EU may use that function for its importer. ECHA does state the separate route of a voluntary submission through an EU-based legal entity, described above.
• Fees outside Belgium, Hungary and Italy. No current ECHA list of national fees was found, and the national pages of other countries were not read.
• A candle or a cleaning wipe. ECHA’s answers of 2020 name scented candles and cleaning wipes as cases where an article carries a mixture, and send the reader to its guidance on substances in articles. CLP labels among articles only explosive ones (Art. 4(8)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 4, paragraph 8Click opens the article on EUR-Lex.), and no article names candles. Whether the wax or the wipe’s liquid is a mixture that needs its own submission, or part of an article that needs none, is not answered by any text read. No official guidance read covers it beyond ECHA’s pointer to its guidance on substances in articles.
• Which country has appointed ECHA. Art. 45(1a)Regulation (EC) No 1272/2008, CLP (classification, labelling and packaging), consolidated text of 1 January 2027Article 45, paragraph 1aClick opens the article on EUR-Lex. lets a country do it from 1 January 2027. The list of appointed bodies in ECHA’s copy of 21 September 2025 shows national bodies, and none names ECHA.