Regulation (EU) 2026/405 was published in the Official Journal of the European Union on 02.03.2026 and entered into force on 23.03.2026. By way of derogation, pursuant to Article 37 of Regulation (EU) 2026/405, it shall apply only from 23.09.2029; this shall not apply to Article 4(3) of Regulation (EU) 2026/405, which shall apply to films and polymers in films at the latest from 23.03.2032, nor to Article 4(4) of Regulation (EU) 2026/405, which shall apply to certain intentionally added organic substances where their share amounts to at least 10% by weight of the total mass of substances excluding water, at the latest from 23.03.2034. This article provides an overview of the key developments introduced by Regulation (EU) 2026/405.
I. Background and Regulatory Objective
The former Regulation (EC) No 648/2004 constituted the relevant legal framework for detergents and surfactants, but no longer adequately reflected current market developments. In particular, new product forms, refill models, the growing volume of online trade, digitalisation and the objectives of the European Green Deal made revision necessary. Regulation (EU) 2026/405 addresses these developments directly: it establishes clear legal requirements and fair conditions of competition while ensuring a high level of protection of human health and the environment. In doing so, it incorporates the aforementioned market developments and links detergents law with digitalisation and the objectives of the European Green Deal.
II. Fundamental Differences in Structure and Regulatory Approach
Regulation (EU) 2026/405 differs from Regulation (EC) No 648/2004 in two central respects. First, it introduces an expanded scope of regulated concepts. Whereas the former Regulation (EC) No 648/2004, in Article 2, defined only basic terms such as “detergent”, “surfactant” and “placing on the market”, the new Regulation (EU) 2026/405 establishes a comprehensive system of differentiated definitions. Newly defined terms include, in particular, “manufacturer” (Article 2, point 20), “authorised representative” (Article 2, point 19), “importer” (Article 2, point 27) and “distributor” (Article 2, point 40). This differentiation is aligned with the New Legislative Framework (NLF) and allows for a precise allocation of obligations throughout the supply chain.
Second, the Regulation marks a shift from a product-centred approach to an actor-centred approach. The former Regulation (EC) No 648/2004 focused on product requirements and regulated the obligations of actors only in a rudimentary manner. By contrast, Regulation (EU) 2026/405 adopts a comprehensive actor-based approach. Chapter III (Articles 8 to 16) of Regulation (EU) 2026/405 lays down in detail the obligations of manufacturers, authorised representatives, importers and distributors, as well as special cases concerning quasi-manufacturers and the packaging or repackaging carried out by importers and distributors.
III. Overview of the Main Substantive Innovations
1. Manufacturer’s obligation to carry out conformity assessment
A significant innovation of Regulation (EU) 2026/405 is that responsibility for conformity assessment is expressly assigned to the manufacturer. Pursuant to Article 8(2), in conjunction with Annex IV to Regulation (EU) 2026/405, the manufacturer must draw up the technical documentation and, within the framework of internal production control, demonstrate in a traceable manner that the detergent or surfactant concerned complies with the requirements of Regulation (EU) 2026/405.
Annex IV lays down Module A (internal production control), under which the manufacturer assesses and documents, on its own responsibility, the conformity of the detergent or surfactant with the requirements of the Regulation. Manufacturers alone are responsible for conducting the conformity assessment procedure. This requires the compilation of technical documentation demonstrating compliance of the detergent or surfactant with the applicable provisions.
2. Digital Product Passport
The digital product passport is now also introduced into detergents law and is regulated in Chapter V (Articles 21 to 25) of Regulation (EU) 2026/405 and Annex VI thereto. Under Article 21 of Regulation (EU) 2026/405, manufacturers shall create a digital product passport for each detergent and for each surfactant intended for end-users. The mandatory information is laid down principally in Article 21(2) of Regulation (EU) 2026/405 and includes information on product identification, the manufacturer, composition and conformity with the requirements of the Regulation.
Articles 22 and 23 of Regulation (EU) 2026/405 lay down requirements as to the technical design of the digital product passport. It must be ensured that the digital product passport interoperates seamlessly with the product passport under Regulation (EU) 2024/1781, i.e. the Ecodesign Regulation. Pursuant to Article 24 of Regulation (EU) 2026/405, the Commission is to establish a central product passport register enabling both the Commission and the competent national authorities to access the relevant product information. In addition, the digital product passport is of benefit to the customs authorities now integrated into the system: they are granted access and may, for imports from third countries, require the registration identifier as a condition for release for free circulation under customs law; see Article 25 of Regulation (EU) 2026/405.
3. Extended scope: detergents containing micro-organisms
Another substantive innovation concerns the express inclusion of detergents containing micro-organisms. Whereas Regulation (EC) No 648/2004 did not regulate this product type separately, Article 5 of Regulation (EU) 2026/405, with reference to Annex II thereto, now lays down specific requirements relating, in particular though not exclusively, to placing on the market, storage and use.
The products concerned must, when placed on the market, have, in accordance with European or international standards or test methods, a standard microbial count of at least 1×10^5 colony-forming units (CFU) per millilitre or gram of product; see Annex II, point 5, to Regulation (EU) 2026/405. Such a detergent must furthermore have a minimum storage period of not less than 18 months and, at the end of that storage period, must still have, in accordance with European or international standards or test methods, a standard microbial count of at least 1×10^4 CFU per millilitre or gram of product; see Annex II, point 6, to Regulation (EU) 2026/405. Moreover, detergents containing micro-organisms may be placed on the market only where safe use for human health and the environment has been demonstrated by means of a risk assessment in accordance with the method to be laid down by the Commission pursuant to Article 30(6) of Regulation (EU) 2026/405; see Annex II, point 7, to Regulation (EU) 2026/405.
4. Extension of biodegradability requirements to films or polymers in films and other organic substances
Regulation (EC) No 648/2004 imposed biodegradability requirements exclusively on surfactants. It distinguished between two stages: primary biodegradability, whereby the surface-active properties of the surfactant had to be degraded, and ultimate aerobic biodegradability, whereby the surfactant had to be completely broken down into carbon dioxide, water and mineral salts of any other elements present. If a surfactant fulfilled the stricter criterion of ultimate aerobic biodegradability, it could be placed on the market without further restriction. If it fell below that threshold, a derogation was possible for detergents used in the industrial or institutional sector, provided that the surfactant at least met the threshold for primary biodegradability.
Pursuant to Article 3(1), in conjunction with Article 4(1), of Regulation (EU) 2026/405, detergents and surfactants may be made available on the market only where they comply with the biodegradability requirements laid down in Annex I, Part A; the new Regulation thereby retains those requirements in principle. The exemption already existing under Regulation (EC) No 648/2004 for surfactants used as disinfectants is continued in Article 4(2) of Regulation (EU) 2026/405 and aligned with Regulation (EU) No 528/2012 concerning biocidal products.
The principal difference from the predecessor Regulation, however, lies in the gradual extension of biodegradability requirements to films or polymers in films and to other organic substances. No later than 23.03.2032, films or polymers in films must comply with the biodegradability requirements laid down in Annex I, Part B; see Article 4(3) of Regulation (EU) 2026/405. No later than 23.03.2034, this shall also apply to other organic substances — except surfactants, films and polymers in films — intentionally added in a concentration of at least 10% by weight of the total mass of substances excluding water, which must comply with the biodegradability criteria set out in Annex I, Part C, unless an exemption is provided for in Annex I, Part D; see Article 4(4) of Regulation (EU) 2026/405. Recital (11) of Regulation (EU) 2026/405 reflects the fact that the persistence risk in wastewater is not limited to surfactants, but may equally concern further constituents of detergents.
5. Review obligation concerning phosphate limit values
The Regulation also provides for a review obligation in relation to phosphate limit values. By 23.03.2028, the Commission is to assess whether the existing limits for phosphorus and phosphorus compounds can be further reduced and whether comparable limits should in future also be introduced for product categories not yet covered, such as hand dishwashing detergents, hard-surface cleaning products, and laundry and dishwashing detergents used in the industrial and institutional sector; see Article 34(2) of Regulation (EU) 2026/405. That assessment is to take into account, in addition to environmental impacts, the availability of low-phosphorus or phosphorus-free alternatives and the economic consequences of any replacement of phosphorus-containing substances.
6. Extended and systematised labelling requirements
Labelling is now regulated in significantly greater detail in Regulation (EU) 2026/405 and is set out in a separate Chapter IV (Articles 17 to 20 of Regulation (EU) 2026/405). Article 17 of Regulation (EU) 2026/405 lays down the general labelling requirements and requires the labelling of all detergents and surfactants supplied in unit packaging or by refill, while laundry detergents, dishwashing detergents and surface cleaning products intended for consumers must additionally indicate dosage information. Article 18 of Regulation (EU) 2026/405 governs the permissible forms of labelling and allows, in addition to the physical label, the use of a digital label. Article 19 of Regulation (EU) 2026/405 sets out the technical and substantive requirements for digital labels, including accessibility, searchability, accessibility for persons with disabilities and an obligation of availability for ten years. Article 20 of Regulation (EU) 2026/405 complements these provisions for distance sales and requires the clearly visible display, in the offer, of the labelling information and the unique product identifier.
7. Information obligations along the supply chain
Regulation (EU) 2026/405 expands the hitherto manufacturer-centred regulatory approach of Regulation (EC) No 648/2004 and lays down comprehensive, role-specific information and due diligence obligations for all economic actors in the supply chain. Manufacturers, authorised representatives, importers and distributors are each subject to graduated obligations. Particular importance attaches to the question under which circumstances an importer or distributor assumes the position of manufacturer and must therefore comply with the manufacturer’s full set of obligations. This is the case where that operator places detergents or surfactants on the market under its own name or trade mark, modifies them in such a way that conformity with the Regulation may be affected, or supplies directly to end-users a surfactant produced exclusively for the manufacture of detergents.
Where operators merely package or repackage products already placed on the market, without affecting their conformity, they are not subject to original manufacturer obligations. They must, however, indicate their identity on the packaging and retain a copy of the original labelling information; sale by refill is not intended to fall within that activity; see Recital (27) of Regulation (EU) 2026/405.
8. Comprehensive market surveillance rules
Regulation (EU) 2026/405 is based on the general market surveillance framework laid down in Regulation (EU) 2019/1020 and specifies that framework for detergents and surfactants in Chapter VI. Articles 26 and 27 of Regulation (EU) 2026/405 establish a two-stage procedure. First, the market surveillance authority shall require the economic operator, within a reasonable period, to bring the product into conformity. If this does not occur, it may provisionally order measures such as prohibitions on making the product available on the market or withdrawals and recalls, and must immediately notify those measures, together with the grounds therefor, to the Commission and the other Member States; see Article 26(6) of Regulation (EU) 2026/405.
If neither another market surveillance authority nor the Commission raises objections within three months, the measure is deemed justified; see Article 26(8) of Regulation (EU) 2026/405. Where objections are raised, the Commission shall decide under the safeguard clause procedure by means of an implementing act; if it confirms the measure, all Member States must remove the non-compliant product from their markets, whereas otherwise the Member State concerned must withdraw the measure; see Article 27 of Regulation (EU) 2026/405. The objective is to ensure a coordinated and uniform level of protection throughout the Union and to avoid uncoordinated national action.
Conclusion
Regulation (EU) 2026/405 replaces Regulation (EC) No 648/2004 with a comprehensively modernised regulatory framework. The key development concern the differentiated design of the obligations of all economic actors, the integration of digital product information obligations, the strengthening of market surveillance and the express consideration of online trade. Economic actors would be well advised to use the remaining period until the Regulation becomes fully applicable for a systematic compliance review and for the implementation of the necessary adjustments.
In parallel, Article 36 of Regulation (EU) 2026/405 lays down transitional provisions for products placed on the market under the previous legal regime. Products which were placed on the market before 23.09.2029 in accordance with Regulation (EC) No 648/2004 and comply with its requirements may continue to be made available on the market without any time limitation; by contrast, for products which are still placed on the market under the previous legal regime between 23.09.2029 and 23.09.2030, further making available is permitted only until 23.09.2030.
Irrespective of this, the material requirements that apply in stages — in particular the requirements concerning the biodegradability of films/polymers in films (Article 4(3)) and of further organic substances (Article 4(4)) — must be considered separately in light of their own respective dates of application. Finally, amendments to national law are to be expected, in particular as regards the competences of market surveillance authorities and the design of sanctions.
Against that background, an amendment of the German Wasch- und Reinigungsmittelgesetz (hereinafter: WRMG) will be necessary. There are currently no known plans for a national adaptation of the WMRG.
Do you have any questions about this news item or would you like to discuss it with the author? Please feel free to contact: Martin Ahlhaus and Nicole Rauch
