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)

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.

(23) In order to safeguard the functioning of the internal market and to ensure that the objective of providing a high degree of protection of human health and the environment is achieved, it is necessary to establish that detergents and surfactants from third countries entering the Union market, including via online sales, also comply with this Regulation. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. It is also necessary to lay down rules for importers to ensure that the detergents and surfactants placed on the market comply with those requirements. Importers and authorised representatives should ensure that the documentation drawn up by manufacturers is available for inspection by the competent national authorities. Provision should be made for importers and, where applicable, authorised representatives to ensure that a digital product passport has been created for detergents and end-user surfactants.

(24) Since importers play a key role in guaranteeing the compliance of imported detergents and surfactants in the Union market, when placing a detergent or surfactant on the market importers should indicate on the product label their name, registered trade name or registered trade mark, as well as their postal and electronic address and telephone number.

(25) As distributors make a detergent or surfactant available on the market after it has been placed on the market by the manufacturer or importer, distributors should act with due care in relation to the applicable requirements. Distributors should also ensure that their handling of the detergent or surfactant does not adversely affect its compliance with this Regulation.

(26) Since distributors, importers and, where applicable, authorised representatives are close to the marketplace and have an important role in ensuring product compliance, they should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the detergent or surfactant concerned.

(27) Importers and distributors that either place a detergent or surfactant on the market under their own name or trademark or modify a detergent or surfactant in such a way that compliance with this Regulation could be affected should be considered to be manufacturers and should therefore assume the obligations of manufacturers. Similarly, importers and distributors making available on the market to end-users a surfactant which was not produced for supply to end-users but to producers of detergents should assume the role of manufacturers and, among others, create a digital product passport. In other cases, economic operators that only package or repackage a detergent or surfactant already placed on the market by other economic operators should be able to prove that compliance with this Regulation has not been affected, by indicating their identity on the package and by keeping a copy of the original labelling information. Packaging and repackaging activities should be understood as providing products to end-users in individual packaging and should not cover refill sales.

(28) Since industrial and institutional detergents are used by specialised personnel outside the domestic sphere, they are subject to different requirements than consumer detergents. In order to avoid risks for the health of consumers or for the environment and to facilitate market surveillance activities, industrial and institutional detergents should be clearly identified by their label.

(29) To ensure a high degree of protection of human health, given the wide availability of detergents and end-user surfactants and the high risk of accidental poisoning, in particular among children, the Member States’ appointed bodies under Regulation (EC) No 1272/2008 supporting the emergency health response should have access to qualitative and quantitative information on the composition of detergents and end-user surfactants, even if not required under that Regulation. Therefore, before such products are placed on the market, manufacturers and, where applicable, their importer or authorised representative should provide an ingredients data sheet for detergents and end-users surfactants which are mixtures not hazardous for human health. In addition, distributors making available on the market the products in Member States other than those in which the products are already available, should also provide the ingredients data sheet. In order to optimise the communication of the information, the obligations in this Regulation should build upon the system related to emergency health response already established under Regulation (EC) No 1272/2008, as it is already familiar to many economic operators and poison centres. The Commission should be empowered to set out the technical requirements for fulfilling the obligation to provide the ingredients data sheet.

(30) Labels communicate important use and safety information to users, for example, the presence in detergents and surfactants of skin or respiratory sensitisers such as allergenic fragrances, preservatives or enzymes. By providing information on the content of those substances on the labels of detergents and surfactants it is possible for users with allergies or allergic predispositions to make informed choices, and potential reactions related to the use of detergents and surfactants are thus reduced. It is therefore necessary to establish labelling requirements for detergents and surfactants.

(31) Since the labelling of detergents and surfactants could fall under multiple Union legal acts, the information on detergents’ and surfactants’ labels needs to be streamlined so that when similar information stemming from different Union legal acts is required on detergents’ and surfactants’ labels, that information is provided only once in accordance with the stricter rules. That streamlining would, on the one hand, improve the readability and understandability of labels by end-users and, on the other, reduce the administrative burden on manufacturers.

(32) Fragrance substances are organic compounds with characteristic, usually pleasant, odours, which are widely used in detergents as well as in many other products such as perfumes and other perfumed cosmetics. Those substances could cause an allergic reaction upon contact, especially for sensitised persons, even when contained in low concentrations. Therefore, it is important to provide information on the presence of individual allergens in detergents so that sensitised persons can avoid contact with the substance to which they are allergic. Specific labelling requirements should therefore be established that would apply only where the fragrance allergens are not to be labelled under Regulation (EC) No 1272/2008. This would not only prevent an unnecessary administrative burden being placed on economic operators but also ensure that consumers or other end-users receive that information presented in a clear manner, thereby providing a high degree of protection of human health for sensitised persons.

(33) Additional labelling requirements are needed for certain substances, such as preservatives, in order to ensure a high degree of human health protection. The labelling requirements for preservatives should therefore cover not only those preservatives intentionally added by the manufacturer to the detergent, but also those that ensue from its constituent mixtures and which are often referred to as ‘carry-over preservatives’.

(34) Information on the correct amount of detergent that consumers need to use when undertaking cleaning activities, namely dosage information, should be included on the label of consumer laundry detergents, consumer automatic dishwasher detergents and consumer detergents for surfaces in order to prevent the potential over-use of detergents, thus reducing the total amount of detergent and surfactant entering the environment.

(35) Digital labelling could improve the communication of labelling information both by avoiding overcrowded physical labels and by allowing users to rely on various reading options available only for digital formats, such as increased font, automatic search, loudspeakers or translation into other languages. Digital labelling could therefore increase readability, ease of use and comprehension of labels for consumers, including vulnerable and visually impaired consumers. The provision of digital labels could also lead to a more efficient management of the labelling obligations by economic operators, by facilitating the update of labelling information, reducing labelling costs and permitting a more targeted provision of information to users. Therefore, economic operators should be allowed to provide certain labelling information for detergents only through the digital label, subject to certain conditions ensuring a high degree of protection for users.

(36) To avoid imposing an unnecessary administrative burden on economic operators and since the digital label is complementary to the physical one, economic operators should be able to decide whether to use digital labels or to provide all the information on a physical label only. The choice to provide a digital label should rest with manufacturers and importers, who are responsible for providing an accurate set of labelling information.

(37) Digital labelling could also create challenges for vulnerable population groups with no or insufficient digital skills and accentuate the digital divide. For that reason, the specific information to be provided on a digital label only should reflect the current level of digital readiness and the particular situation of users of detergents, as well as the readiness of the wireless and other technological infrastructure necessary for allowing unrestricted access to the information. In addition, all the labelling information concerning the protection of health and of the environment, as well as minimum-use instructions for detergents, should remain on the physical label, to enable consumers and other end-users to make informed choices before buying the detergent and to ensure its safe handling.

(38) For detergents and surfactants sold to end-users through refill, it should be possible for a more extensive amount of information to be provided digitally only, in order to fully reap not only the benefits offered by digitalisation, but also the large environmental benefits in terms of reduction of packaging and related packaging waste that the practice of refill sales offers. Nevertheless, end-users should receive in a physical form at least simplified dosage instructions for consumer laundry detergents and information on fragrance allergens and preservatives, in order to avoid the risk of allergic reactions.

(39) To ensure a level playing field among economic operators making detergents available on the market, and to protect consumers and other end-users, general requirements for digital labelling should be laid down. For example, economic operators should ensure free and easy access to digital labels and that mandatory labelling information required under this Regulation be separated from other information.

(40) Given the current development of digital skills, economic operators should also provide labelling information by alternative means to consumers and other end-users who are not able to access the digital label. That obligation should be imposed as a safety measure to reduce any potential risks caused by the unavailability of the labelling information, in particular as regards refilled detergents or end-user surfactants, where more labelling information may be provided on a digital label only.

(41) Since detergents and end-user surfactants have the same use and present the same risks irrespective of the format in which they are made available on the market, economic operators making such products available on the market through refill should ensure that those products comply with the same requirements as products in individual packaging. In addition, consumers should receive the required labelling information when opting for refilled detergents, and minimum safety requirements should be set out for refill stations. The refill sale of detergents should therefore be explicitly covered by this Regulation in order to ensure a high degree of protection of human health and of the environment and a level playing field for economic operators.

(42) In order to keep pace with technological developments and new means of sale, while ensuring good information for consumers and efficient market surveillance activities, the labelling information of detergents and surfactants should be indicated in the case of distance sales, including via online marketplaces.

(43) Ensuring traceability of a detergent or surfactant throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities’ task of tracing economic operators who make non-compliant detergents or surfactants available on the market.

(44) Manufacturers should create a digital product passport to provide information on the compliance of detergents and end-user surfactants with this Regulation. While this Regulation sets out the minimum content of the digital product passport, starting from the EU declaration of conformity, the inclusion of additional information, such as technical documentation, could be envisaged in the future. In order to facilitate checks on detergents or end-user surfactants by market surveillance authorities and to allow the actors in the supply chain, consumers and other end-users, as well as other relevant stakeholders such as civil society organisations and researchers, to access necessary information such as ingredients, the information on the digital product passport should be provided digitally and in a directly accessible and user-friendly manner through a data carrier. The data carrier should be clearly visible to the end-user before any purchase, including where the detergent or end-user surfactant is made available through an online advertisement. Market surveillance authorities, customs authorities, economic operators, consumers and other end-users should therefore have immediate access through the data carrier to the information relevant to them and based on their respective access rights.

(45) To avoid placing costs on companies that are disproportionate to the wider benefits, the digital product passport should be specific to the model of a detergent or end-user surfactant. Detergents or end-user surfactants should be considered as belonging to the same model as long as there are no changes to the formula or to the production that would lead to modifications in the label of the products.

(46) To avoid duplication of investment into digitalisation by all actors involved, including manufacturers, market surveillance authorities and customs authorities, where any other Union law requires a digital product passport for detergents or surfactants, a single digital product passport should be available containing the information required under this Regulation and that other Union law. In addition, the digital product passport established under this Regulation should be fully interoperable with any digital product passport required under other Union law.

(47) In particular, Regulation (EU) 2024/1781 of the European Parliament and of the Council (10) also lays down requirements and technical specifications for a digital product passport, the establishment by the Commission of a digital product passport registry (the ‘registry’) where digital product passport information is stored and the interconnection of the registry with the EU Customs Single Window Certificates Exchange System established by Regulation (EU) 2022/2399 of the European Parliament and of the Council (11). That Regulation could include detergents or surfactants within its scope in the medium term, thus requiring that a digital product passport be available for them.

(48) The digital product passport for detergents and end-user surfactants created under this Regulation should therefore comply with the same requirements and technical elements as those set out in Regulation (EU) 2024/1781, including its technical, semantic and organisational aspects of end-to-end communication and data exchange.

(49) It is crucial to make clear to both manufacturers and users that, by creating the digital product passport for a detergent or end-user surfactant, the manufacturer declares that the product is in compliance with all applicable requirements and that the manufacturer takes full responsibility for that compliance.

(50) Where information is provided only digitally, it is necessary to clarify that such information should be provided through a single data carrier, but be provided separately and be clearly distinguishable from other information. This would facilitate the work of market surveillance authorities and also provide clarity to consumers or other end-users regarding the different pieces of information that are available to them in a digital format.

(51) Chapter VII of Regulation (EU) 2019/1020 of the European Parliament and the Council (12), which establishes the rules regarding controls on products entering the Union market, applies to detergents and surfactants. The authorities in charge of those controls, which in almost all Member States are the customs authorities, are to perform them on the basis of risk analysis as referred to in Articles 46 and 47 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (13), its implementing acts and the corresponding guidance. This Regulation should therefore not modify in any way Chapter VII of Regulation (EU) 2019/1020 or the way in which the authorities in charge of controls on products entering the Union market organise themselves and perform their activities.

(52) In addition to the framework of controls established by Chapter VII of Regulation (EU) 2019/1020, customs authorities should be able to automatically verify that a digital product passport exists for imported detergents and surfactants subject to this Regulation in order to strengthen the controls at the Union’s external borders and prevent non-compliant detergents and surfactants from entering the Union market.

(53) Where detergents and end-user surfactants coming from third countries are placed under the customs procedure of release for free circulation, the reference to a digital product passport for those detergents and surfactants should be made available to the customs authorities by the economic operator. Such reference should correspond to a unique registration identifier communicated to the economic operator by the registry. Customs authorities should verify as a minimum that the unique registration identifier and the relevant commodity code for the detergent or end-user surfactant provided or made available to them correspond to the data that are stored in the registry. This would allow customs authorities to verify that a digital product passport for imported detergents and surfactants exists. To carry out that automatic verification, the interconnection between the registry and the EU Customs Single Window Certificates Exchange System should be used.

(54) The data included in the digital product passport are intended to allow customs authorities to enhance and facilitate risk management and enable the controls at the border to be better targeted. Therefore, customs authorities should be able to retrieve and use the data included in the digital product passport and the related registry for carrying out their tasks in accordance with Union law, including for risk management in accordance with Regulation (EU) No 952/2013.

(55) The automatic verification by customs authorities of the digital product passport reference for detergents and surfactants entering the Union market should not replace or modify the responsibilities of the market surveillance authorities, but should instead complement the overall framework for controls on products entering the Union market. The market surveillance authorities should, in line with Regulation (EU) 2019/1020, carry out checks of the data contained in digital products passports, checks on products within the market and, in the case of suspension of release for free circulation by the authorities designated for controls at the Union’s external borders, determine the compliance and serious risks of products pursuant to Chapter VII of Regulation (EU) 2019/1020.

(56) Market surveillance is an essential instrument for ensuring the proper and uniform application of Union law. Regulation (EU) 2019/1020 sets out the framework for market surveillance of products that are subject to Union harmonisation law. Member States should therefore organise and carry out market surveillance of detergents and surfactants in accordance with that Regulation.

(57) Regulation (EC) No 648/2004 provides for a safeguard procedure which allows the Commission to examine the justification for a measure taken by a Member State in respect of detergents and surfactants considered to constitute a risk. In order to increase transparency, it is necessary to improve the previous safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States. The previous system should be replaced by a procedure under which interested parties are informed of measures intended to be taken with regard to detergents and surfactants posing a risk to health or the environment. Market surveillance authorities should be allowed, in cooperation with the relevant economic operators, to act at an early stage in respect of such detergents and surfactants. The Commission should, by means of implementing acts, with the application of the examination procedure laid down in Regulation (EU) No 182/2011 of the European Parliament and of the Council (14), determine whether a provisional measure in respect of a detergent or surfactant posing a risk is justified. That specific safeguard procedure applies without prejudice to routine controls performed by market surveillance authorities in accordance with Regulation (EU) 2019/1020.

(58) Experience gained regarding the application of Regulation (EC) No 648/2004 has shown that detergents and surfactants which were compliant with the applicable requirements have nevertheless, in specific cases, posed a risk to health or the environment. Provisions should be made to ensure that market surveillance authorities take action against any detergent or surfactant posing a risk to health or the environment, even if the product is compliant with legal requirements. The Commission should, by means of implementing acts, with the application of the examination procedure laid down in Regulation (EU) No 182/2011, determine whether a provisional measure, taken in respect of compliant detergents or surfactants which a Member State finds to pose a risk to health and safety of persons or to the environment, is justified.

(59) In order to take into account technical and scientific progress or new scientific evidence, and the level of digital readiness, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the Annexes to this Regulation to adapt them to technical progress; further supplementing the general requirements on digital labelling; amending the labelling information able to be provided in digital format only; amending the limit of the fragrance allergens when individual risk-based concentration limits for fragrance allergens are established under Regulation (EC) No 1223/2009 of the European Parliament and of the Council (15) or adding new fragrance allergens; and amending the existing biodegradability requirements to introduce biodegradability requirements for substances and mixtures other than surfactants in detergents, including detergent capsules, when new scientific evidence so requires or allowing for derogation from such criteria in duly justified cases. The Commission should also be empowered to amend, by means of delegated acts, the specific information to be included in the digital product passport, as well as the information to be included in the registry. In addition, in order to facilitate the work of customs authorities in relation to detergents and surfactants and the requirements set out in this Regulation, the Commission should be empowered to adopt delegated acts amending the Annex to this Regulation containing the list of commodity codes, as set out in Annex I to Council Regulation (EEC) No 2658/87 (16), and product descriptions of detergents and surfactants. When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (17). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(60) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish the detailed technical requirements for the digital product passport for detergents and surfactants. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(61) In view of the need to ensure a high degree of human health and environmental protection and the need to take into account new developments based on scientific facts, the Commission should submit to the European Parliament and to the Council a report on the application of this Regulation. The Commission should assess, inter alia, if this Regulation is achieving its objectives, taking into account the impact on small and medium-sized enterprises. As regards phosphorus, the report should contain an assessment of the feasibility of further reducing phosphorus limits, with a view to phasing out its use in future, if possible. As regards the most harmful substances, the Commission should, while taking into account the achievements under other relevant Union law, assess the need to include provisions in this Regulation on the presence of those substances in detergents and surfactants, for the purpose of ensuring fulfilment of the goals set in the European Green Deal concerning the generic approach to risk management for the most harmful substances in consumer products, and with a view to possibly phasing out the use of such substances, if appropriate. In addition, as regards biocidal active substances, the Commission should assess the need to introduce stricter rules to avoid the circumvention of the approval scheme established by Regulation (EU) No 528/2012. In order to ensure a high degree of protection of human health and the environment, foster innovation and boost competitiveness, the Commission should assess the safety requirements for detergents containing micro-organisms. In order to facilitate the transition to a fully circular economy, the Commission should assess the introduction of targets for renewable raw materials and recycled content for detergents.

(62) This Regulation introduces the possibility of providing part of the mandatory labelling information only on digital labels in certain situations and requires the creation of a digital product passport for detergents and surfactants. It is therefore necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, for Member States to set up the administrative infrastructure necessary for its application and for the Commission to prepare the implementation of the digital product passport’s technical requirements. Consequently, the application of this Regulation should be deferred to a date by which those preparations can reasonably be finalised.

(63) In order to ensure legal certainty and to prevent waste, economic operators need to be able to sell stock that is either in the distribution chain, or in storage, at the date of application of this Regulation. It is therefore necessary to provide for transitional arrangements that allow the making available on the market of detergents and surfactants that have been placed on the market in accordance with Regulation (EC) No 648/2004 before that date without those products having to comply with this Regulation. Distributors should therefore be able to supply such detergents and surfactants, namely stock that is already in the distribution chain, before the date of application of this Regulation.

(64) To further ensure legal certainty and prevent waste, it is important that economic operators be able, for a limited period after the date of application of this Regulation, to sell stock that is not yet in the distribution chain. To that end, transitional arrangements should also be made that allow the placing on the market of detergents and surfactants that are not yet in the distribution chain at the date of application of this Regulation, without those products having to comply with this Regulation, provided that they comply with Regulation (EC) No 648/2004. Manufacturers and importers should therefore be able to place on the market such detergents and surfactants, namely stock that is not yet in the distribution chain, after the date of application of this Regulation. Given the objective of that transitional period, that possibility should be strictly limited in time to one year after that date and, in particular, it should not be possible to make such stock available on the market after that one-year period.

(65) Since the objectives of this Regulation, namely to guarantee the functioning of the internal market while ensuring that detergents and surfactants on the market fulfil the requirements that provide for a high degree of protection of health and the environment, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(2) ‘consumer laundry detergent’ means a detergent for laundry placed on the market for use by non-professionals, including in public laundrettes;

(3) ‘consumer automatic dishwasher detergent’ means a detergent placed on the market for use in automatic dishwashers by non-professionals;

(4) ‘detergent containing micro-organisms’ means a detergent to which one or more micro-organisms have been intentionally added, either on their own or via one of the components of the detergent;

(5) ‘industrial and institutional detergent’ means a detergent placed on the market for use only outside the domestic sphere, carried out by specialised personnel;

(6) ‘cleaning’ means the process by which an undesirable deposit is degraded or dislodged from a substrate or from within a substrate and brought into a state of solution or dispersion;

(7) ‘substance’ means a substance as defined in Article 3, point (1), of Regulation (EC) No 1907/2006;

(8) ‘mixture’ means a mixture as defined in Article 3, point (2), of Regulation (EC) No 1907/2006;

(9) ‘micro-organism’ means a micro-organism as defined in Article 3(1), point (b), of Regulation (EU) No 528/2012;

(12) ‘end-user surfactant’ means a surfactant made available on the market to professional users or consumers;

(13) ‘ultimate aerobic biodegradation’ means the level of biodegradation achieved when the substance or mixture is totally used by micro-organisms in the presence of oxygen, resulting in its breakdown to carbon dioxide, water and mineral salts of any other elements present, as measured by test methods listed in Part A of Annex I, and new microbial cellular constituents (biomass);

(14) ‘films’ means water-soluble polymeric films used as detergents capsules;

(15) ‘making available on the market’ means any supply for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(16) ‘placing on the market’ means the first making available on the Union market;

(17) ‘manufacturer’ means any natural or legal person that manufactures or has a detergent or a surfactant designed or manufactured, and that places that detergent or surfactant on the market under their name or trade mark;

(18) ‘authorised representative’ means any natural or legal person established within the Union that has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks;

(19) ‘importer’ means any natural or legal person established within the Union that places a detergent or surfactant from a third country on the Union market;

(20) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a detergent or surfactant available on the market;

(21) ‘economic operator’ means the manufacturer, authorised representative, importer or distributor;

(22) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with this Regulation;

(23) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;

(24) ‘recall’ means a recall as defined in Article 3, point (22), of Regulation (EU) 2019/1020;

(25) ‘withdrawal’ means a withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020;

(26) ‘corrective action’ means a corrective action as defined in Article 3, point (16), of Regulation (EU) 2019/1020;

(27) ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;

(28) ‘data carrier’ means a data carrier as defined in Article 2, first paragraph, point (29), of Regulation (EU) 2024/1781;

(29) ‘unique product identifier’ means a unique product identifier as defined in Article 2, first paragraph, point (30), of Regulation (EU) 2024/1781;

(30) ‘unique formula identifier’ means a unique formula identifier as referred to in Part A, point 5, of Annex VIII to Regulation (EC) No 1272/2008;

(31) ‘unique operator identifier’ means a unique operator identifier as defined in Article 2, first paragraph, point (31), of Regulation (EU) 2024/1781;

(32) ‘digital product passport’ means a set of data specific to a product that contains the information set out in Part A of Annex VI and that is accessible via electronic means through a data carrier in accordance with Article 21(4);

(33) ‘digital product passport service provider’ means a digital product passport service provider as defined in Article 2, first paragraph, point (32), of Regulation (EU) 2024/1781;

(34) ‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013;

(35) ‘EU Customs Single Window Certificates Exchange System’ means the system established by Regulation (EU) 2022/2399;

(36) ‘individual packaging’ means packaging in which the detergent or end-user surfactant is made available on the market and which is intended to accompany the content to the place of use;

(37) ‘refill’ means the on-site operation by which a detergent or surfactant offered by an economic operator to end-users in the course of a commercial activity, whether in return for payment or free of charge, is filled in a packaging;

(38) ‘refill station’ means a place where an economic operator offers to end-users a detergent or surfactant that can be acquired through refill, either manually or through automatic or semi-automatic equipment;

(40) ‘end-user’ means any natural or legal person residing or established in the Union to whom a detergent or surfactant has been made available on the market, either as a consumer outside of any trade, business, craft or profession or as a professional end-user in the course of its industrial or professional activities.

CHAPTER II

PRODUCT REQUIREMENTS

Article 3

Making available on the market and free movement

Article 4

Biodegradability

(a) they are included in the Union list of approved active substances as referred to in Article 9(2) of Regulation (EU) No 528/2012, or included in Annex I to that Regulation;

(b) they are included in the review programme as set out in Commission Delegated Regulation (EU) No 1062/2014 (19); or

(c) they are constituents of disinfectants which can be made available on the market or used in accordance with Article 55 of Regulation (EU) No 528/2012.

Article 5

Detergents containing micro-organisms

Detergents containing micro-organisms shall comply with the requirements set out in Annex II.

Article 6

Limitations on the content of phosphates and other phosphorus compounds

Detergents listed in Annex III shall comply with the limitations on the content of phosphates and other phosphorus compounds set out in that Annex.

Article 7

Animal testing

(a) the ingredient is widely used and cannot be replaced by another ingredient capable of performing a similar function; and

(b) the human health or environmental problem is substantiated and the need to conduct animal testing is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.

The Commission shall address its decision granting a derogation to all Member States and shall immediately communicate it to them and to the relevant economic operators.

CHAPTER III

OBLIGATIONS OF ECONOMIC OPERATORS

Article 8

Obligations of manufacturers

Where compliance of a detergent or end-user surfactant with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, before placing the product on the market manufacturers shall:

(a) create a digital product passport in accordance with Article 21;

(b) ensure that the data carrier is available in accordance with Article 21(4); and

(c) include a reference of the digital product passport in the registry referred to in Article 24(1) (the ‘registry’).

When deemed appropriate with regard to the performance of, or the risks presented by, a detergent or surfactant, manufacturers shall carry out sample testing of such detergent or surfactant, investigate, and, if necessary, keep a register of complaints, of non-compliant detergents or surfactants and of recalls of such detergents or surfactants, and shall keep distributors informed of any such monitoring.

Article 9

Authorised representative

The mandate shall require the authorised representative to do at least the following:

(a) verify that, in accordance with Article 8(2), the digital product passport has been created, the relevant information on the digital product passport has been included in the registry, the technical documentation has been drawn up and the conformity assessment procedure has been carried out;

(b) keep the technical documentation at the disposal of national market surveillance authorities, and the digital product passport available, for 10 years from the date on which the detergent or surfactant covered by those documents has been placed on the market;

(c) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the compliance with this Regulation of the detergent or surfactant, in a language that can be easily understood by that authority;

(d) where it has reason to believe that a detergent or surfactant covered by the mandate poses a risk to human health or to the environment, inform the manufacturer and the market surveillance authorities thereof;

(e) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by a detergent or surfactant covered by the mandate; and

(f) terminate the mandate and inform the competent national authorities of such termination if the manufacturer does not comply with its obligations under this Regulation.

(a) provide and, where needed, update the ingredients data sheet in accordance with Article 8(6);

(b) keep the information contained in the ingredients data sheet confidential;

(c) verify that detergents and surfactants comply with the labelling requirements set out in Article 17(1), (3), (4) and (5), Article 18(1), Article 19(1) and (2) and, where applicable, Article 17(2), Article 18(2) and Article 19(3); and

(d) make best efforts to verify that the documentation and information provided by the manufacturer in accordance with Article 8(7) demonstrates compliance of the products with this Regulation.

Article 10

Obligations of importers

(a) the manufacturer has carried out the conformity assessment procedure and drawn up the technical documentation referred to in Article 8(2);

(b) the information and documentation provided by the manufacturer in accordance with Article 8(7) demonstrate compliance with this Regulation; and

(c) the manufacturer has created the digital product passport referred to in Article 8(2), point (a), the data carrier is available in accordance with Article 21(4) and the relevant information on the digital product passport has been included in the registry.

Article 11

Obligations of distributors

(a) the detergent or surfactant is accompanied by the required documents and by a label containing the information referred to in Article 17(3) and (4), in the conditions set out in Article 17(5);

(b) where a digital label is provided, the requirements in Article 19(1), points (a), (d), (e) and (h), Article 19(2) and, where applicable, Article 17(2), Article 18(2) and Article 19(3) are met; and

(c) the data carrier is available in accordance with Article 21(4).

Article 12

Supply through refill

Without prejudice to Regulations (EU) 2023/988 (20) and (EU) 2025/40 (21) of the European Parliament and of the Council as regards safety and hygiene requirements for refill including the risk of confusion with foodstuff, where detergents or end-user surfactants are made available on the market through refill, the economic operator making the product available to end-users shall ensure that:

(a) risk mitigation measures are applied to minimise the exposure of humans, especially of children, including by preventing children from using the refill station unsupervised and by training appropriately their staff; and

(b) the detergents or end-user surfactants provided through a refill station do not react with each other in a way that could endanger human health.

Article 13

Cases in which obligations of manufacturers apply to importers and distributors

Importers or distributors shall be considered manufacturers for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 8 where they:

(a) place a detergent or surfactant on the market under their name or trade mark;

(b) modify a detergent or surfactant already placed on the market in such a way that compliance with this Regulation could be affected; or

(c) make a surfactant that is not an end-user surfactant available on the market to end-users.

Article 14

Packaging and repackaging by importers and distributors

(a) ensure that the package bears the importer’s or distributor’s name, registered trade name or registered trade mark, postal and electronic address and telephone number, preceded by the words ‘packaged by’ or ‘repackaged by’;

(b) keep a specimen of the original information referred to in Article 17(3) or (4) at the disposal of the market surveillance authorities for 10 years from the date on which the detergent or surfactant has been placed on the market; and

(c) keep the reference to the unique product identifier at the disposal of the market surveillance authorities for 10 years from the date on which the detergent or end-user surfactant has been placed on the market.

Article 15

Identification of economic operators

(a) any economic operator who has supplied them with a detergent or a surfactant; and

(b) any economic operator to whom they have supplied a detergent or a surfactant.

Article 16

Confidentiality of the ingredients data sheet

Appointed bodies and medical personnel shall keep confidential the information included in the ingredients data sheet. They may only use such information:

(a) to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency; or

(b) where requested by a Member State, the Commission or the European Chemicals Agency, to undertake a statistical analysis to identify where improved risk management measures might be needed.

CHAPTER IV

LABELLING

Article 17

General labelling requirements

Article 18

Forms of labelling

(a) on a physical label; or

(b) on a digital label and duplicated on a physical label.

(a) the labelling information referred to in Part C of Annex V may be provided on a digital label only;

(b) the labelling information referred to in Part A, points 1(a), (c) and (d), of Annex V may be provided on a physical label only.

Article 19

Requirements for digital labelling

(a) all labelling information referred to in Part A of Annex V and, where applicable, Part B of that Annex, are provided together in one place and separated from other information;

(b) the information on the digital label is searchable;

(c) the information on the digital label is accessible to all users in the Union;

(d) the information on the digital label is accessible via the data carrier referred to in Article 21(2), point (h);

(e) the information on the digital label is presented in a way that also addresses the needs of vulnerable groups, including persons with disabilities, and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups;

(f) the digital label is accessible through digital technologies widely used and compatible with all major operating systems and browsers;

(g) the digital label remains available for a period of 10 years from the date on which the detergent or surfactant is placed on the market, including in cases of insolvency, liquidation or cessation of activity in the Union of the economic operator that created it, or for a longer period as required under other Union law covering the information that it contains;

(h) where the information on the digital label is accessible in more than one language, the choice of language is not to be conditioned by the geographical location from which it is accessed by the end-user.

(a) upon oral or written request by the end-user; or

(b) where the digital label is temporarily unavailable, including at the time of purchase.

Economic operators shall provide the information referred to in the first subparagraph independently of a purchase of a detergent or surfactant and free of charge.

Article 20

Distance sales

Where detergents or surfactants are made available on the market through distance sales, the offer shall clearly and visibly indicate the label information referred to in Article 17, and a digital copy of the data carrier or the unique product identifier.

CHAPTER V

DIGITAL PRODUCT PASSPORT

Article 21

Digital product passport

(a) correspond to a specific model of detergent or end-user surfactant;

(b) state that compliance of the detergent or end-user surfactant with this Regulation has been demonstrated;

(c) contain at least the data set out in Part A of Annex VI;

(d) be accurate, complete and up-to-date;

(e) be available in the language or languages required by the Member State in which the detergent or end-user surfactant is made available on the market;

(f) be accessible to consumers or other end-users, market surveillance authorities, customs authorities, the Commission and other economic operators in accordance with the access rights laid down pursuant to paragraph 10, point (d);