EkotoxInfo 03/2026 

EkotoxInfo 03/2026 

We provide a selection of important information in the field of EU legislation on chemicals and products, chemical management:

  1. Biocidal products – Update of the fee levels in Poland
  2. Drinking Water Directive – EU Positive Lists
  3. Ethanol – ECHA RAC supports its approval in disinfectants
  4. Formaldehyde – EU Restriction in articles
  5. One in five hazardous mixtures not reported to poison centres
  6. Detergents and surfactants – new regulation published
  7. Chromium(VI) compounds: planned regulation, extended authorisations and timeline
  8. SVHCs classifications transfer to CLP
  9. REACH Conference 2026

Biocidal products – Update of the fee levels in Poland

The Regulation of the Minister of Health of 29 January on fees for activities related to the authorisation of a biocidal product for placing on the market has been published in the Journal of Laws.

Ekotox news webpages: https://ekotox.eu/news/update-of-the-fee-levels-for-biocidal-products-charged-by-the-authority/
Ekotox EU BPR webpages: https://ekotox.eu/biocides/

Drinking Water Directive – EU Positive Lists

ECHA has launched a new online tool for industry to notify its plans to update the EU Positive Lists of substances that are approved for use in materials that come into contact with drinking water.

More information: https://ekotox.eu/news/drinking-water-directive-eu-positive-lists/
Ekotox webpages: https://ekotox.eu/chemicals-management/

Ethanol – ECHA RAC supports its approval in disinfectants

European Chemicals Agency’s Biocidal Products Committee concluded that ethanol can be approved for use in disinfectants. A.I.S.E. welcomed the decision, highlighting ethanol’s key role in infection prevention and everyday hygiene. Final approval now depends on an implementing act from the European Commission, while future regulatory discussions may continue under the CLP framework.

More information: https://ekotox.eu/news/echa-finally-adopts-opinion-on-ethanol-and-supports-its-approval-in-disinfectants/
Ekotox webpages: https://ekotox.eu/biocides/

Formaldehyde – EU Restriction in articles

The new regulations introduce additional restrictions on the emission of this substance from various products placed on the EU market to better protect consumer health from its harmful effects.

More information: https://ekotox.eu/news/formaldehyde-eu-restriction-in-articles/
Ekotox webpages: https://ekotox.eu/chemicals-management/

One in five hazardous mixtures not reported to poison centres

ECHA Forum’s pilot enforcement project found that 19 % of the checked hazardous mixtures were not notified to poison centres. But findings are covering more problems on EU markets. Implications for improvements are now matter of discussions between authorities and industry.

More information: https://ekotox.eu/news/one-in-five-hazardous-mixtures-not-reported-to-poison-centres/
Ekotox webpages: https://ekotox.eu/

Detergents and surfactants – new regulation published

On March 2, 2026, the new Regulation (EU) 2026/405 on detergents and surfactants was published, replacing the existing Regulation (EC) 648/2004. This regulation will enter into force on March 22, 2026, and will apply from September 23, 2029. In practice, this creates a new, comprehensive regulatory system for the entire detergent category in the EU. Transitional periods are also provided for, allowing the continued introduction and sale of products that comply with the old regulations within a specified timeframe.

More information: https://ekotox.eu/news/new-regulation-on-detergents-and-surfactants/
Ekotox webpages: https://ekotox.eu/detergents-and-sufactants/

Chromium(VI) compounds: planned regulation, extended authorisations and timeline

EC has published a Q&A document containing the most important information on the restrictions on the use of chromium(VI) compounds under REACH and the planned regulation amending the provisions on chromium compounds and their use.

More information: https://ekotox.eu/news/chromiumvi-compounds-planned-regulation-extended-authorisations-and-timeline/
Ekotox webpages: https://ekotox.eu/chemicals-management/

SVHCs classifications transfer to CLP

The list of substances identified as SVHCs to be automatically transfered to CLP Annex VI for ED, PBT, vPvB properties.

More information: https://ekotox.eu/news/the-list-of-substances-identified-as-svhcs-to-be-automatically-transfered-to-clp-annex-vi-for-ed-pbt-vpvb-properties/
Ekotox webpages: https://ekotox.eu/clp-regulation/

REACH Conference 2026

Chemical Management & EU Chemicals Legislation & Products Safety – REACH Conference 2026

16th REACH Conference will take place in Poland – Katowice-Chorzów on September 30 – October 1 2026.

More information: https://trainingeu.eu/

The list of substances identified as SVHCs to be automatically transfered to CLP Annex VI for ED, PBT, vPvB properties

The list of substances identified as SVHCs to be automatically transfered to CLP Annex VI for ED, PBT, vPvB properties

49 Proposed new entries to be inserted in Annex VI

58 Entries proposed to be revised in Annex VI

Overview of entries with ED HH, ED ENV, PBT and vPvB hazard classes to be transferred to CLP from the Candidate List of substances of very high concern (SVHC), active substances in biocide products and plant protection products regulations. Grouped by type of entry (i.e. new, updated or deleted): https://circabc.europa.eu/ui/group/a0b483a2-4c05-4058-addf-2a4de71b9a98/library/3a42dc10-5b2a-493b-8c71-ed8aeafb6444/details

Ekotox website: https://ekotox.eu/substances-of-very-high-concern-svhc/

Chromium(VI) compounds: planned regulation, extended authorisations and timeline.

Chromium(VI) compounds: planned regulation, extended authorisations and timeline.

EC has published a Q&A document containing the most important information on the restrictions on the use of chromium(VI) compounds under REACH and the planned regulation amending the provisions on chromium compounds and their use.

In 2013, chromium compounds were added to the REACH authorization list. Businesses wishing to continue using chromium compounds were required to submit an authorization application and specify the conditions for their use. The number of applications submitted was so high that ECHA still experiences significant delays in issuing its opinions.

Therefore, in 2023, the European Commission requested ECHA to prepare a dossier for the substance Cr(VI) under Annex XV of the REACH Regulation. ECHA developed several restriction options in the Annex XV dossier, aiming to identify the most appropriate option for controlling the risks associated with these substances while encouraging their substitution with alternatives. The dossier will be submitted to the Commission, which will prepare a draft regulation amending the provisions on chromium compounds.

In response to emerging questions regarding the workflow and technical issues related to issuing permits, EC has prepared a Q&A document in which it provides answers to the most frequently asked questions.

Source: Q&A towards a restriction of Cr(VI) substances under reach

Validity of existing authorisations

The European Commission extended the deadline so that companies already authorised to use chromium (VI) substances do not have to prepare and submit review reports when a Commission decision is not expected before a new REACH restriction on these substances enters into force.

Timeline

ECHA’s scientific committees are currently preparing their opinions on the Cr(VI) restriction. Their final opinion is expected by the end of 2026.

The Commission Regulation on the restriction, which will replace the current REACH authorisation for these substances, is expected by the end of 2028.

Source: https://echa.europa.eu/sk/view-article/-/journal_content/title/echa-weekly-11-february-2026

Ekotox website: https://ekotox.eu/reach-regulation/

New regulation on detergents and surfactants

New regulation on detergents and surfactants

On March 2, 2026, the new Regulation (EU) 2026/405 on detergents and surfactants was published, replacing the existing Regulation (EC) 648/2004. This regulation will enter into force on March 22, 2026, and will apply from September 23, 2029. In practice, this creates a new, comprehensive regulatory system for the entire detergent category in the EU. Transitional periods are also provided for, allowing the continued introduction and sale of products that comply with the old regulations within a specified timeframe.

Regulation (EU) 2026/405 on detergents and surfactants, and repealing Regulation (EC) 648/2004 was published in the Official Journal of the European Union on 2 March 2026.

The regulation shall enter into force on 22 March 2026 and shall apply from 23 September 2029.

The regulation means several major changes for those who trade such products within the EU. Among other things, rules are introduced on digital product passports and digital labeling, stricter requirements for biodegradability, and new rules for refill sales.

The updated Detergents Regulation expands the definition of detergents to include new products, such as those containing micro-organisms. It also introduces an animal testing ban.

The revision removes previous overlaps with CLP labelling rules and introduces digital labelling and a digital product passport (DPP).

Manufacturers located outside the EU may place detergents and surfactants on the EU market, provided they appoint an authorised representative established in the EU.

The following transition periods apply:

Detergents and surfactants placed on the market before September 23, 2029 that comply with the old detergent Regulation (EC) No 648/2004 may continue to be made available without any time limit.

Detergents and surfactants placed on the market between September 23, 2029 and September 22, 2030 that comply with the old detergent Regulation (EC) No 648/2004 may continue to be made available until September 23, 2030.

Labelling requirements

All detergents and surfactants, regardless of whether they are sold in individual packaging or provided through refill, must be accompanied by a label. When these products are supplied directly to end users via refill stations, the responsible economic operator is required to provide both the physical label and the data carrier specified in Article 21(2)(h). These must be made available for every package that is refilled with detergent or surfactant.

The fundamental labeling requirements established under the 2004 regulation continue to apply. In accordance with Article 17(3), labels for detergents and surfactants must include the mandatory information listed in Part A of Annex V of the new regulation. This covers the essential product and traceability details. This means that in addition to the product name or trade name, labels must display a type or batch number (or another traceable identifier) and the UFI (Unique Formula Identifier), indicated as “UFI:” followed by the code. The label must also identify the manufacturer (and, where relevant, the importer) by providing their name or registered trade name or trademark, a single postal address within the EU, an email address, and a telephone number. Instructions for use and any special precautions must also be included.

For products intended just for professional use in industrial or institutional settings, this restriction must be explicitly stated on the label. Labels for surfactants must additionally confirm that the substance is suitable for use in detergents. Certain ingredients must also be listed on the label in accordance with the rules set out in Part A, point 1(h) of Annex V with the fragrance allergens listed in part D of Annex V.

In addition, labels for consumer laundry detergents, consumer automatic dishwasher detergents, and consumer surface-cleaning detergents must include dosage instructions, as required by Part B of Annex V.

In accordance with Article 18 of the Regulation, the labelling information may be provided either on a physical label or on a digital label, provided that a physical label is still included. An exception applies for the information included in Part C of Annex V, which may be supplied in digital form only. While certain details such as traceability elements e.g. type number, batch number, the manufacturer’s and, if applicable, the importer’s name, registered trade name or trademark, email address, telephone number, postal address indicating a single point in the Union, and product’s name and trade name are required to be provided on the physical label only.

For detergents and surfactants sold via distance sales, the online offer must clearly and visibly present the labelling information required under Article 17, along with a digital version of the data carrier or the unique product identifier.

Microorganisms

One of the most significant developments in the revised EU Detergents Regulation is the introduction of a dedicated risk assessment framework for microorganisms used in detergent formulations.

This framework will be established through a delegated act under Article 26, which will define the methodology for evaluating the safety of microbial ingredients.

At present, this Article 26 delegated act has not yet been published. As a result, the specific provisions relating to microorganisms are not currently operational.

Until the microbial risk assessment methodology is finalised and implemented, microbial-based cleaning products already placed on the market are not subject to the new provisions introduced by the revised regulation.

Regulation (EU) 2026/405: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600405 

Ekotox website: https://ekotox.eu/detergents-and-sufactants/

One in five hazardous mixtures not reported to poison centres

One in five hazardous mixtures not reported to poison centres

ECHA/NR/26/08

ECHA Forum’s pilot enforcement project found that 19 % of the checked hazardous mixtures were not notified to poison centres.

11 February 2026 – Inspectors in 18 EU/EEA countries checked 1 597 mixtures to verify whether industry complies with the obligation to notify hazardous mixtures to national poison centres. This is regulated under the EU’s Classification, Labelling and Packaging (CLP) Regulation. These notifications are crucial for poison centres to provide an adequate medical response in case of exposure to hazardous mixtures. Of all checked mixtures, 19 % were not notified to the authorities.

Chris Van den hole, the Working Group Chair of this pilot project said:

“Missing notifications of the necessary information to the poison centres undermine the effectiveness of emergency response. Therefore, inspectors take these findings very seriously and initiated numerous enforcement actions to bring companies to compliance.

“To improve the situation, we have listed recommendations for market actors, authorities and consumers in our report.”

The pilot project also aimed to raise the duty holders’ awareness of their legal obligations, for example, to place the Unique Formula Identifier (UFI) on the label of their products. The 16-digit, alphanumerical UFI code is a vital tool used by the poison centres to rapidly identify a mixture following an accidental poisoning. In 15 % of inspected mixtures, the required UFI was missing from the product label.

Full text – Source ECHA: https://echa.europa.eu/-/one-in-five-hazardous-mixtures-not-reported-to-poison-centres

Ekotox website: https://ekotox.eu/safety-data-sheet-sds/

Formaldehyde – EU Restriction in articles

Formaldehyde – EU Restriction in articles

On July 14, 2023, the European Commission adopted Commission Regulation (EU) 2023/1464, which amends Annex XVII to Regulation (EC) No 1907/2006 (REACH) regarding the use of formaldehyde and formaldehyde-releasing substances. The new regulations introduce additional restrictions on the emission of this substance from various products placed on the EU market to better protect consumer health from its harmful effects.

Formaldehyde is widely used in many products and materials, but it is also classified as a hazardous substance, including one with carcinogenic properties. Therefore, the European Union has decided to tighten regulations regarding its presence in products and emissions into indoor air.

The new regulations aim to reduce consumer exposure to formaldehyde, especially in closed environments such as homes and vehicle interiors. The regulation entered into force 20 days after its publication in the Official Journal of the EU and is directly applicable in all member states.

In accordance with the content of the new restriction: Formaldehyde and formaldehyde-releasing substances:

1. Shall not be placed on the market in articles, after 6 August 2026, if, under the test conditions specified in Appendix 14, the concentration of formaldehyde released from those articles exceeds: 

(a) 0,062 mg/m3 for furniture and wood-based articles; 

(b) 0,080 mg/m3 for articles other than furniture and wood-based articles. 

The first subparagraph shall not apply to: 

(a) articles in which formaldehyde or formaldehyde releasing substances are exclusively naturally present in the materials from which the articles are produced; 

(b) articles that are exclusively for outdoor use under foreseeable conditions; 

(c) articles in constructions, that are exclusively used outside the building shell and vapour barrier and that do not emit formaldehyde into indoor air; 

(d) articles exclusively for industrial or professional use unless formaldehyde released from them leads to exposure of the general public under foreseeable conditions of use; 

(e) articles for which the restriction laid down in entry 72 applies; 

(f) articles that are biocidal products within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council (*); 

(g) devices within the scope of Regulation (EU) 2017/745; 

(h) personal protective equipment within the scope of Regulation (EU) 2016/425; 

(i) articles intended to come into contact directly or indirectly with food within the scope of Regulation (EC) No 1935/2004; 

(j) second-hand articles. 2. Shall not be placed on the market in road vehicles after 6 August 2027 if, under the test conditions specified in Appendix 14, the concentration of formaldehyde in the interior of those vehicles exceeds 0,062 mg/m3.

2. Shall not be placed on the market in road vehicles after 6 August 2027 if, under the test conditions specified in Appendix 14, the concentration of formaldehyde in the interior of those vehicles exceeds 0,062 mg/m3 .

The first subparagraph shall not apply to: 

(a) road vehicles exclusively for industrial or professional use unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use; 

(b) second-hand vehicles.

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1464

Ekotox website: https://ekotox.eu/restrictions/

  

ECHA finally adopts opinion on ethanol and supports its approval in disinfectants 

ECHA finally adopts opinion on ethanol and supports its approval in disinfectants 

European Chemicals Agency’s Biocidal Products Committee concluded that ethanol can be approved for use in disinfectants. A.I.S.E. welcomed the decision, highlighting ethanol’s key role in infection prevention and everyday hygiene. Final approval now depends on an implementing act from the European Commission, while future regulatory discussions may continue under the CLP framework.

Brussels, 24 February 2026 – Yesterday, on 23 February 2026, the European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) has concluded that ethanol may be approved for use in hand and general disinfectants.

A.I.S.E. welcomes this positive and fundamental step. It demonstrates that Member States recognise ethanol’s indispensable role in infection prevention, along with its substantial socio-economic value for Europe’s healthcare systems, industries and daily life. This decision marks responsible progress on an issue that directly affects public health, consumer safety and supply chain resilience.

Ethanol remains a cornerstone of hygiene across the EU — relied upon every day in hospitals, long term care facilities, food production, workplaces and households. The BPC’s decision helps secure its continued availability under the BPR and supports the many sectors and professionals who depend on it to protect people’s health.

But the regulatory process is not over. 

This is a first milestone, but it will now be in the hands of the European Commission to deliver an Implementing Act which reflects the outcome of the BPC and confirms the approval of ethanol as an active substance for biocidal uses.

This will conclude the biocidal process, but the broader question of ethanol’s potential reclassification will then move into the EU Classification, Labelling and Packaging (CLP) framework.

This means ethanol remains at regulatory risk, and our collective engagement must continue.

Source: All news – ECHA

Ekotox website: https://ekotox.eu/biocides/ 

  

Ensure full compliance with current legislation and avoid fines

Ensure full compliance with current legislation and avoid fines

In an environment of constantly evolving environmental standards and chemical regulations, it is crucial to maintain continuous monitoring of the legislative framework.

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TEMPLATE: Quarterly monitoring of legal regulations

Period: JANUARY – MARCH 2025
Sector: Waste Management / Chemical Management / Air

Drinking Water Directive – EU Positive Lists

Drinking Water Directive – EU Positive Lists

ECHA/NR/26/02

ECHA has launched a new online tool for industry to notify its plans to update the EU Positive Lists of substances that are approved for use in materials that come into contact with drinking water.

By using the ECHA Industry Portal companies can indicate those substances that they wish to keep, add or remove from the European Positive Lists. The notifications under the Drinking Water Directive are prepared in the IUCLID format.

To help the notifiers prepare their notifications of intentions in IUCLID, ECHA has published:

a manual on “How to prepare a Drinking Water Directive Notification of intention”;

a guidance document dedicated to notifications of intention (DWD Guidance Volume IV); and a video tutorial on the generation of the notification of intention IUCLID dossier.

ECHA invites all impacted parties to familiarise themselves with the manual, guidance and tutorial before preparing their notifications.

After a notification of intention has been submitted, notifiers have 12 months to submit their application. From January 2027, notifiers can start submitting their applications to amend the European Positive Lists.

Full text – Source ECHA: https://echa.europa.eu/-/echa-asks-companies-to-start-notifying-intentions-under-the-drinking-water-directive

Ekotox website: https://ekotox.eu/

Update of the fee levels for biocidal products charged by the Authority

Update of the fee levels for biocidal products charged by the Authority

As of 6 February 2026, the Regulation of the Minister of Health on fees for activities related to the authorisation of a biocidal product for placing on the market enters into force.

The Regulation of the Minister of Health of 29 January on fees for activities related to the authorisation of a biocidal product for placing on the market has been published in the Journal of Laws. The Regulation governs the fees charged by the Authority in Poland, including:

  • Submission of an application for the granting of an authorisation for placing a biocidal product on the market
  • Making a change to the authorisation for placing on the market
  • Making a change of the responsible entity being the holder of the authorisation

The fees cover both authorisations for placing a biocidal product on the market under the national procedure as well as under the European procedure.

The update concerns the fee structure and the level of rates related to the evaluation of active substances, the granting of authorisations for biocidal products, and advisory services of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Source: Journal of Laws 2026, item 126

Ekotox website: https://ekotox.eu/biocides/