Regulation (EU) 2026/405 of the European Parliament and of the Council of 11 February 2026 on detergents and surfactants, and repealing Regulation (EC) No 648/2004 (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) The conditions for placing on the market, and for making available on the market, detergents and surfactants for detergents have been harmonised through Regulation (EC) No 648/2004 of the European Parliament and of the Council (3). That Regulation sets out requirements related to the biodegradability of surfactants, restrictions or bans on surfactants on grounds of biodegradability, limitations on the content of phosphates and other phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher detergents, information that manufacturers are to hold at the disposal of the Member States’ competent authorities and medical personnel, and rules on the labelling of detergents, including regarding fragrance allergens.

(2) The Commission’s evaluation of Regulation (EC) No 648/2004 concluded that that Regulation has achieved its objectives to a large extent. However, that evaluation also identified a number of weaknesses and areas for further improvement. In recent years, the regulatory framework for chemicals has changed radically, creating duplications and a lack of coherence in the rules applicable to detergents and in particular the relevant information requirements. There is therefore a need to ensure consistency and to eliminate duplicated information requirements.

(3) Certain new market developments, in particular the development of detergents containing micro-organisms and the refill sale of detergents, are either completely or partially not covered by Regulation (EC) No 648/2004. In addition, the number of products offered for sale via the Internet is increasing and such online sales pose particular enforcement issues in situations where there is neither a manufacturer established in the Union, nor an importer. On the other hand, digitalisation offers opportunities for simplification, burden reduction and increased ease of use and understandability of safety and use information that are currently being missed. It is therefore necessary to take account of new products and practices and step up digitalisation efforts in line with the overarching objectives of the Union, especially in terms of sustainability and green and digital transitions. In addition, refill sales should be encouraged as a specific waste-prevention measure necessary for meeting reuse and refill targets, in line with the European Green Deal set out in the Commission communication of 11 December 2019, and the new Circular Economy Action Plan for a cleaner and more competitive Europe, set out in the Commission communication of 11 March 2020. In order to further the Union’s transition towards a circular economy, the reuse and refill of packaging should be encouraged and promoted. Economic operators should also endeavour to make detergents available on the market to consumers in other sustainable sales forms, for example in recyclable packaging that allows consumers to refill the appropriate packaging at home, while ensuring the safety of consumers.

(4) The Fitness Check of the most relevant chemicals legislation, which did not include Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4), highlighted the complexity of the Union regulatory framework for chemicals and attributed that complexity to the large number of interconnected product-specific and sector-specific legal acts. The Fitness Check pointed out that enforcement issues are reported by market surveillance authorities concerning products entering the Union from third countries through online sales. It also pointed out that there is room for simplification in the communication of information through labels to product users and found that the use of innovative tools for communicating product information is currently not being taken advantage of. It is therefore necessary to simplify the current rules in order to reduce the burden on economic operators, improve consumer understanding and facilitate market surveillance. Regulation (EC) No 648/2004 should therefore be replaced.

(5) Decision No 768/2008/EC of the European Parliament and of the Council (5) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for a revision of that legislation. The new legal framework for detergents and surfactants should be aligned to the extent possible to those common principles and reference provisions.

(6) In order to ensure legal certainty and a level playing field for economic operators, the existing definition of ‘detergent’ should be extended to cover the newly developed detergents containing intentionally added micro-organisms. That definition should also cover products that support the cleaning process when used together with a laundry detergent or an automatic dishwasher detergent, as well as products modifying the odour of fabrics, given the ancillary role those products have for fulfilling the cleaning function. References to surfaces include the surface of fruits and vegetables.

(7) As surfactants are the main ingredients in detergents, the existing biodegradability requirements should be maintained. Since surfactants are primarily sold in business-to-business transactions in order to be used in the manufacturing of detergents, they do not need to be subject to the same requirements as detergents. Therefore, minimum rules for surfactants should be laid down, namely rules on labelling information and the obligation on manufacturers to draw up technical documentation. To avoid placing an unnecessary administrative burden, the manufacturer should be obliged to create a digital product passport and provide the ingredients data sheet for emergency health response only where surfactants are made available on the market directly to consumers or other end-users. In addition, provisions on refill sales should also apply to end-user surfactants.

(8) The European Green Deal has set a goal to better protect human health and the environment as part of an ambitious approach to tackle pollution from all sources and move towards a toxic-free environment. As part of that approach, this Regulation should complement rules set out in existing legislative instruments.

(9) Since the Union already has one of the most comprehensive and protective regulatory frameworks for chemicals, supported by the most advanced knowledge base globally, this Regulation does not affect the application of existing Union law relating to aspects of protection of human health, of safety and of the environment not covered by this Regulation. This Regulation should, in particular, apply without prejudice to Regulations (EC) No 1907/2006, (EC) No 1272/2008 (6) and (EU) No 528/2012 (7) of the European Parliament and of the Council.

(10) Surfactants are surface-active agents that help break down the interface between water and oils or dirt. They are one of the main ingredients used in detergents. Surfactants can, however, pose a risk to the environment as they are discharged into sewage systems or directly into surface waters. To prevent any adverse effects that surfactants might have on the environment, it is necessary to set requirements ensuring that surfactants are completely biodegradable, whether they are placed on the market on their own and intended for use in detergents or whether they are contained in detergents.

(11) There are some substances used in detergents, other than surfactants, which can remain in wastewater after use and, if not removed by wastewater treatment plant operators through costly processes, persist and build up in the environment. In order to facilitate innovation and address potential risks to human health and the environment, and to support the objectives of Directive (EU) 2024/3019 of the European Parliament and of the Council (8), ambitious targets should be set out for the introduction of biodegradability criteria and corresponding test methods for other ingredients in detergents, prioritising ingredients with potentially higher impacts on the environment. The Commission should, in a first stage, develop biodegradability criteria for water-soluble polymeric films used to encapsulate detergents and for all polymers within such films, and in a second stage should develop such criteria for other organic substances used in high concentration in detergents, representing at least 10 % of the product. To ensure an equal treatment between products irrespective of their liquid or solid form and to avoid dilution, that percentage should be calculated out of the total mass of substances, including various solvents, without taking into account the water content. The Commission should also determine suitable test methods, to ensure uniform implementation and effective market surveillance across the Union. In addition, for reasons of legal clarity and predictability, realistic timelines should be set for manufacturers to adapt their product formulations to meet the biodegradability criteria to be developed by the Commission for either the films or the polymers within films and the organic substances in high concentrations. To ensure flexibility of the rules in duly justified cases, the Commission should be empowered to introduce derogations from the biodegradability requirements to ensure that the efficiency, availability and affordability of detergents is not affected. Finally, to ensure a high degree of protection of the environment, the Commission should also assess the feasibility of introducing biodegradability criteria for organic substances present in lower concentrations or of lowering the minimum threshold. Such a comprehensive and staged approach towards biodegradability should ensure steady progress towards biodegradable products, within realistic timelines. To give manufacturers time to adapt product formulations, sufficient transitional periods should be provided and relevant test criteria should be established well in advance.

(12) Phosphorus is another key ingredient used in detergents. However, phosphorus and its compounds cause damage to ecosystems and aquatic environments as they contribute to eutrophication. Significant progress is expected to be made for the recovery of phosphorus from urban wastewater under Directive (EU) 2024/3019. It is nevertheless important to continue addressing the issue at source by limiting the content of phosphorus in the types of detergents which are used in the highest volumes. Therefore, to further ensure a high degree of protection of the environment, and to reduce the contribution of detergents to eutrophication, it is necessary to maintain the harmonised limits on the content of phosphates and phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher detergents. Given the significant consequences eutrophication can have, the Commission should assess the feasibility of further reducing such limits and of introducing new limits for other categories of products and, where appropriate, adopt a proposal to amend such essential elements of this Regulation.

(13) In recent years, novel cleaning products have been developed that contain living micro-organisms as active ingredients. Micro-organisms have their own biology and response to the environment. Due to their ability to proliferate, there is a clear difference between conventional and microbial detergents. Therefore, the inherent hazards and arising risks are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to survive and multiply in different environments and to produce a range of different metabolites and toxins of potential toxicological significance.

(14) Since micro-organisms are not subject to registration pursuant to Regulation (EC) No 1907/2006 or to any other Union law requiring manufacturers to demonstrate that the intended use is safe, they should be eligible for use in detergents only to the extent that they have been clearly identified and supported by data demonstrating that their use is safe. Harmonised rules governing the safe use of micro-organisms in detergents should therefore be established. To ensure a high degree of protection of human health and the environment and a level playing field for economic operators, the Commission should set out a methodology for the risk assessment of detergents containing micro-organisms. Such methodology should be as comprehensive as possible and cover all known risks, including for specific categories of products such as those in a spray format or those to be used on surfaces in contact with food.

(15) In accordance with Directive 2010/63/EU of the European Parliament and of the Council (9), it is necessary to replace, reduce or refine testing on animals, with a view to phasing out the use of animals for testing as soon as possible. The placing on the market of detergents and surfactants which have been the subject of animal testing in order to meet the requirements of this Regulation should therefore generally be prohibited while nevertheless allowing for the use of historic data. The Commission should provide for a derogation, where appropriate, to ensure a high degree of protection of human health and the environment, and should communicate any such decision granting a derogation to Member States and relevant economic operators.

(16) To ensure a high degree of protection of public interest, and to guarantee fair competition on the internal market, economic operators should be responsible for the compliance of detergents and surfactants with this Regulation in relation to their respective roles in the supply chain. Whenever appropriate, manufacturers and importers should carry out sample testing of the detergents and surfactants that they have made available on the market, in order to protect the health and safety of consumers and the environment.

(17) All economic operators intervening in the supply and distribution chain should take appropriate and effective measures to ensure that they make available on the Union market only detergents and surfactants which are in compliance with this Regulation. It is therefore necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

(18) In order to enable economic operators to demonstrate, and the competent authorities to verify, that detergents and surfactants made available on the market comply with this Regulation, it is necessary to provide for a conformity assessment procedure. Decision No 768/2008/EC establishes modules for conformity assessment procedures, from the least stringent to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, that Decision specifies the conformity assessment procedures which can be chosen from among those modules.

(19) The manufacturers, having detailed knowledge of the design and production process, are best placed to ensure compliance of the detergent or surfactant with this Regulation. Manufacturers should therefore be solely responsible for carrying out the conformity assessment procedure for detergents and surfactants. Module A set out in Annex II to Decision No 768/2008/EC should be applicable for the conformity assessment of detergents and surfactants. Manufacturers should also put together technical documentation demonstrating compliance of the detergent or surfactant with the relevant rules and test methods.

(20) Given that detergents and surfactants can have a long shelf life and to ensure coherence with the requirements to keep documentation under Regulation (EC) No 1272/2008 which are applicable to the majority of detergents, manufacturers should keep the technical documentation, the digital product passport and, where applicable, the digital label for a period of 10 years from the date on which the detergent or surfactant covered by that technical documentation, digital product passport or digital label has been placed on the market.

(21) To facilitate compliance of the manufacturers with their obligations under this Regulation, manufacturers established in the Union should be allowed to appoint an authorised representative to carry out specific tasks on their behalf. Such an appointment should be valid only when accepted in writing by the authorised representative. Moreover, to ensure a clear and proportionate distribution of responsibilities between the manufacturer and the authorised representative, it is necessary to set out the list of tasks with which manufacturers should entrust the authorised representative, as well as the list of tasks which cannot be delegated. Furthermore, to ensure the enforceability and effectiveness of the market surveillance requirements and ensure that only compliant detergents and surfactants are placed on the Union market, there should always be an entity established in the Union responsible for liaising with market surveillance authorities and for ensuring compliance with this Regulation. To that end, manufacturers established outside the Union should appoint an authorised representative established in the Union in respect of the detergents and surfactants which they place on the Union market via distance sale, including via online marketplaces. This Regulation should therefore set out a list of additional tasks with which such manufacturers are to entrust authorised representatives. That list should include an obligation to make best efforts to verify that the information and documentation supplied by the manufacturer demonstrate compliance with this Regulation. Such an obligation should be understood as being a document-based check, as the authorised representative should not be required to conduct detailed investigations or exhaustive analyses of compliance. It would ensure an appropriate protection of human health and the environment whilst respecting, in accordance with the principle of proportionality, the particular role and capacities of authorised representatives.

(22) With a view to facilitating communication between economic operators, market surveillance authorities and consumers, economic operators should indicate and keep up-to-date their contact details, such as a telephone number in addition to postal and email addresses or other communication channels.