In short
Regulation (EU) 2026/405 on detergents and surfactants was published in the Official Journal on 2 March 2026 and entered into force on 22 March 2026. It applies from 23 September 2029, when Regulation (EC) No 648/2004 is repealed. Surfactants must still meet ultimate aerobic biodegradability, now alongside a digital product passport and digital labelling.
Regulation (EU) 2026/405 of the European Parliament and of the Council on detergents and surfactants was adopted in Strasbourg on 11 February 2026, published in the Official Journal on 2 March 2026 and entered into force on 22 March 2026. It applies from 23 September 2029, with the exception of Article 4(3) and (4), and it repeals Regulation (EC) No 648/2004 with effect from the same date. For surfactant suppliers the biodegradability duty is familiar; the product passport, the digital label and the rules for micro-organism products are new.
- New instrument
- Regulation (EU) 2026/405
- Applies from
- 23 September 2029
- Replaces
- Regulation (EC) No 648/2004
- PureSurf status
- F Eco 74.7 % ThCO₂, OECD 301B (GLP); F Pro under final assessment
The biodegradability criterion in Annex I is met with a CO₂ evolution test, the same method family as OECD 301B. How the OECD 301B test works
Transition timeline
The regulation was adopted on 11 February 2026 and gives industry a long runway: the substantive obligations bite in September 2029, and stock already on the market keeps a sell-through window into 2030. Two biodegradability duties sit outside that date and arrive later.
| Milestone | Date | Legal basis |
|---|---|---|
| Published in the Official Journal | 2 March 2026 | OJ publication |
| Entered into force | 22 March 2026 | Article 37, twentieth day after publication |
| Applies from | 23 September 2029 | Article 37, except Article 4(3) and (4) |
| Regulation (EC) No 648/2004 repealed | 23 September 2029 | Article 35 |
| Sell-through for compliant stock placed before 23 September 2029 | Indefinite | Article 36(1) |
| Sell-through for stock placed between 23 September 2029 and 23 September 2030 | Until 23 September 2030 | Article 36(2) |
| Films and polymers within films biodegradable | By 23 March 2032 | Article 4(3), Annex I Part B |
| Other organic substances at 10 %w/w or more biodegradable | By 23 March 2034 | Article 4(4), Annex I Part C |
Citation details verified against the consolidated Official Journal text at eur-lex.europa.eu (ELI: reg/2026/405).
What the regulation covers
Article 1 sets rules for the free movement of detergents and surfactants in the internal market. The definition of a detergent in Article 2 now expressly includes micro-organisms, which closes the gap left by (EC) No 648/2004 for probiotic and enzyme-plus-culture cleaning products. Refill sales and distance sales are covered explicitly, and obligations are allocated across manufacturers, authorised representatives, importers and distributors.
It does not affect the application of REACH, CLP or the Biocidal Products Regulation. A surfactant with an antimicrobial claim still needs its own biocidal pathway; detergent compliance and biocidal authorisation remain separate tracks.
- Detergents and surfactants, consumer and industrial and institutional alike.
- Detergents containing intentionally added micro-organisms (Article 5, Annex II).
- Refill sale, including the label and data carrier at the refill station.
- Distance and online sales, with explicit pre-purchase information duties.
Biodegradability requirements and their timelines
Article 4 keeps ultimate aerobic biodegradability as the core duty for surfactants and for surfactants contained in detergents. Annex I Part A defines the pass criteria: at least 60 % mineralisation in 28 days in a CO₂ evolution, manometric respirometry, closed bottle or MITI test, or at least 70 % in a DOC die-away or modified OECD screening test. Pre-adaptation is not allowed and the 10-day window principle is not applied.
Tests must be run by laboratories working to GLP under Directive 2004/10/EC or accredited under Regulation (EC) No 765/2008. That raises the evidential bar: screening data from a non-GLP, non-accredited laboratory will not carry a dossier.
Two further biodegradability duties phase in later. Films and polymers within films must meet Annex I Part B by 23 March 2032. Other organic substances intentionally added at 10 %w/w or more of the total mass excluding water, other than surfactants and films, must meet Annex I Part C by 23 March 2034, unless a derogation in Part D applies. Surfactants used as approved biocidal disinfectant actives are exempt from Article 4(1) under the conditions in Article 4(2).
The digital product passport
Article 21 introduces the biggest operational change. Before placing a detergent or end-user surfactant on the market, the manufacturer must create a digital product passport for that specific model, stating that compliance has been demonstrated and carrying at least the data in Annex VI Part A. The passport must be accurate, complete, up to date, available in the languages of the Member States where the product is sold, and kept available for 10 years from placing on the market, including after insolvency or liquidation.
The passport is reached through a data carrier linked to a persistent unique product identifier. The carrier must be printed on the label, the packaging or the accompanying documents for bulk, must be indelible and machine readable, must be present at refill stations, must be visible before purchase and must be accompanied by wording such as "Please scan for more comprehensive information on the product".
Passports are registered in a Commission registry (Article 24), and customs authorities verify them through the EU Customs Single Window (Article 25) from 23 September 2029 or from the date the interconnection is operational, whichever is later.
- One passport per product model, created before placing on the market.
- Minimum data set defined in Annex VI Part A, optional data in Part B.
- Ten-year availability, independent of company continuity.
- Access tiers for consumers, market surveillance, customs and other operators.
Labelling and ingredient disclosure
Every detergent and surfactant made available in individual packaging or through refill needs a label (Article 17), carrying the information in Annex V Part A. Consumer laundry detergents, consumer automatic dishwasher detergents and consumer surface detergents additionally need dosage information under Annex V Part B.
Article 18 allows a digital label, but only in addition to a physical label: information in Parts A and B must be duplicated physically, information in Part C may be digital only, and a small set of Part A items (product identity and related points) must stay physical. Article 19 sets the quality rules for digital labels: searchable, accessible across common browsers and assistive technology, available for 10 years, language choice not tied to geolocation, and no tracking of usage beyond what is strictly necessary.
Ingredient disclosure moves into the technical documentation as an ingredients data sheet, which must identify the product, the responsible operator and the ingredients. The manufacturer must also make an ingredients data sheet for emergency health response available where surfactants are supplied directly to consumers or other end-users.
Micro-organism-based products
Detergents containing intentionally added micro-organisms must comply with Annex II. Strains must be deposited with an International Depository Authority, identified by whole genome sequence analysis and named to genus, species and strain level. Genetically modified micro-organisms are not permitted.
Seven pathogens must be absent, including Escherichia coli, Staphylococcus aureus, Salmonella spp and Pseudomonas aeruginosa. Strains must remain susceptible to the major antibiotic classes apart from intrinsic resistance. Products need a plate count of at least 1 × 10⁵ CFU per millilitre or gram at placing on the market, a minimum shelf life of 18 months and at least 1 × 10⁴ CFU per millilitre or gram at end of shelf life, plus a documented safety risk assessment and substantiation of every performance claim.
Animal-testing provisions
Article 7 requires compliance to be established with non-animal test methods validated at Union or international level, and prohibits placing on the market detergents and surfactants whose final formulation, ingredients or combinations of ingredients have been subject to animal testing to meet the requirements of the regulation.
Data acquired before 22 March 2026 may still be used. Derogations are possible only in exceptional circumstances, by Commission implementing decision, where a safety concern arises about an ingredient, potentially after consulting ECVAM.
What formulators need to do before September 2029
The date is distant, but the gating item is data. Biodegradability studies to GLP or accreditation take months to schedule and run, and every passport entry depends on having that evidence and the ingredient identity settled first.
- Audit every surfactant in the portfolio against Annex I Part A: which pass criterion is claimed, which test method, which laboratory status.
- Replace screening data with GLP or accredited study reports; confirm no pre-adaptation and no 10-day window was applied.
- Map films, polymers within films and organic substances above 10 %w/w against the 2032 and 2034 deadlines.
- Collect Annex VI Part A data per product model and decide who owns passport creation and its 10-year hosting.
- Specify the data carrier and unique product identifier with packaging suppliers, including refill stations.
- Rework artwork for the physical and digital label split under Annex V Parts A, B and C.
- Rebuild the ingredients data sheet and the emergency health response sheet in the new format.
- Confirm no ingredient in the portfolio relies on animal-test data generated after 22 March 2026.
- For micro-organism products, secure IDA deposit, genome identification, pathogen screening and shelf-life data.
- Ask suppliers for written confirmation of Annex I compliance and passport-ready data now, not in 2029.
How PureSurf grades position against the new rules
Environmental data is stated per grade. NEXOVANT F Eco reached 74.7 % ThCO₂ in 28 days under OECD 301B (GLP), which clears the 60 % CO₂ evolution criterion in Annex I Part A with margin and comes from a GLP study rather than a screening run. F Pro is under final assessment. Aquatic toxicity is reported as registered EC50 values under OECD 201 (algae, 72 h) and OECD 202 (Daphnia magna, 48 h), and the CLP classification is stated per grade. NEXOVANT is non-mutagenic under OECD 471 (GLP).
For disinfectant applications, SYLVAXIS is DIN EN 1276 compliant and currently at TRL 4. Note that Article 4(2) exempts approved biocidal disinfectant actives from the surfactant biodegradability duty under defined conditions, while biocidal authorisation itself remains a separate pathway.
Frequently asked questions
When does Regulation (EU) 2026/405 apply?
It entered into force on 22 March 2026 and applies from 23 September 2029, with the exception of Article 4(3) and (4), which set later biodegradability deadlines of 23 March 2032 for films and 23 March 2034 for other organic substances.
What replaces Regulation 648/2004?
Regulation (EU) 2026/405 repeals Regulation (EC) No 648/2004 with effect from 23 September 2029. References to the old regulation are read as references to the new one via the correlation table in Annex VIII.
What is a digital product passport for detergents?
A digital record created by the manufacturer for each product model before placing it on the market. It confirms compliance, holds at least the data in Annex VI Part A, is reachable through a data carrier on the label or refill station, and must stay available for 10 years.
Do surfactants need to be readily biodegradable under the new rules?
The legal test is ultimate aerobic biodegradability under Annex I Part A: at least 60 % mineralisation in 28 days in a CO₂ evolution, respirometry, closed bottle or MITI test, or 70 % in a DOC die-away or modified OECD screening test, without pre-adaptation and without the 10-day window. Passing an OECD 301 ready biodegradability test is the cleanest way to evidence it.
What changes for labelling?
A physical label remains mandatory, with Annex V Part A information and dosage data for consumer products. A digital label is allowed in addition and must be searchable, accessible, free of usage tracking and available for 10 years. Part C information may be digital only.
Content last reviewed: by Prof. Katalin Barta Weissert
Part of this topic cluster
Bio-based surfactants: the full pillar overviewRelated topics in this cluster
Evidence from our own portfolio: Compare the NEXOVANT, RHEOSYL and SYLVAXIS grade data















