What changed between the plenary report and the adopted text

Change 2

Removed:SHORT JUSTIFICATION

Added:P9_TC1-COD(2023)0124

Removed:The Council position at first reading reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second-reading stage.

Added:Position of the European Parliament adopted at first reading on 27 February 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council on detergents and surfactants, amending Regulation (EU) 2019/1020 and repealing Regulation (EC) No 648/2004

Added:(Text with EEA relevance)

Added:THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Added:Having regard to the proposal from the European Commission,

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

Added:Having regard to the opinion of the European Economic and Social Committee,

Added:Acting in accordance with the ordinary legislative procedure,

Added:Whereas:

Added:(1) The conditions for placing and making available on the market of detergents and surfactants for detergents have been harmonised through Regulation (EC) No 648/2004 of the European Parliament and of the Council.

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

Added:(3) New market developments, in particular the development of detergents containing micro-organisms and the refill sale of detergents have emerged that are either completely or partially not covered by Regulation (EC) No 648/2004. 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 missed. It is therefore necessary to take account of the newly emerged products and practices and step up the digitalisation efforts in line with the overarching objectives of the Union especially in terms of sustainability, green and digital transition.

Added:(4) The Fitness Check of the most relevant chemicals legislation (excluding Regulation (EC) No 1907/2006 of the European Parliament and of the Council) highlighted the complexity of the Union regulatory framework for chemicals and attributed it to the large number of product and sector specific pieces of legislation with embedded links with each other. It also pointed out that there is room for simplification in the communication of information of overcrowded 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 that the current rules are simplified to reduce burden for economic operators, improve consumer understanding and facilitate market surveillance. Regulation (EC) No 648/2004 should therefore be replaced.

Added:(5) Decision No 768/2008/EC of the European Parliament and of the Council 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.

Added:(6) In order to ensure legal certainty and a level playing field for economic operators, the definition of detergent should cover all products falling in the scope of harmonisation, including the newly developed detergents containing intentionally added micro-organisms. The definition should also cover products for cleaning the surface of fruits and vegetables.

Added:(7) 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 ultimate biodegradability, a minimum set of labelling information and the obligation of economic operators to draw up a technical documentation and to create a product passport.

Added:(8) This Regulation should complement existing rules set out in other legislative instruments and should not affect the application of existing Union legislation relating to aspects of protection of health, of safety and of the environment not covered by this Regulation. This Regulation should, in particular, apply without prejudice to Regulation (EC) No 1907/2006, Regulation (EU) No 528/2012 of the European Parliament and of the Council and to Regulation (EC) No 1272/2008 of the European Parliament and of the Council.

Added:(9) 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 could, 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 could have on the environment, it is necessary to set requirements ensuring that surfactants are completely biodegradable either when placed on the market on their own and intended for use in detergents or when contained in detergents.

Added:(9a) There are substances used in detergents, other than surfactants, which might remain in wastewater after use and, if not removed by wastewater operators in costly processes, they persist and built up in the environment. In order to facilitate innovation and address potential risks to health and the environment, it is necessary to set a mid-term target ensuring that detergents, as a whole, are inherently biodegradable. To give manufacturers time to adapt product formulations, sufficient transition periods should be provided and relevant test criteria should be established well in advance. [Am. 1]

Added:(10) Phosphorus is a keyan ingredient used in detergents. However, phosphorus and its compounds could cause significant damage to ecosystems and aquatic environments as they contribute to eutrophication. To further ensure a high level of protection of the environment, and reduce the contribution of detergents to that phenomenon, it is necessary to establish harmonised limits on the content of phosphates and phosphorus compounds in consumer laundry andcertain consumer automatic dishwasherand industrial detergents. Similar limitations are not required for other types of detergents either because their contribution is not significant or because suitable alternatives are currently not available. [Am. 2]

Added:(11) 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 persist and multiply in different environments and to produce a range of different metabolites and toxins of potential toxicological significance.

Added:(12) Since micro-organisms are not subject to registration under Regulation (EC) No 1907/2006 or any other Union legislation 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, and subject to specific requirements governing their safety. Harmonised rules governing the safety of micro-organisms in detergents as well as relevant test methods for economic operators to demonstrate compliance with those rules should, therefore, be established. Restrictions are required on the format in which detergents containing micro-organisms are placed on the market when sensitising ingredients are included in their composition. To ensure a high level of protection of human health even for sensitised persons, detergents containing micro-organisms and which are placed on the market in a spray format should, therefore, be found safe for use in this format.

Added:(12a) In accordance with Directive 2010/63/EU of the European Parliament and of the Council, it is necessary to replace, reduce or refine testing on animals, with a view to stopping 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 still ensuring the protection of human health and allowing the use of historic data. The Commission should validate relevant alternative testing methods and derogations where appropriate and encourage the sharing of information between all relevant stakeholders to support the development of non-animal testing methods taking into account the applicable Union law on the protection of undisclosed business information and on public access to environmental information. [Am. 3]

Added:(12b) The use of the claim ‘animal testing free’ or similar claims should only be allowed if it is ensured that during the manufacturing and conformity testing no animal testing has occurred. Similarly, manufacturers should only be allowed to claim a product is ‘vegan’ or similar, if no animal-derived ingredients, such as gelatine, cholesterin or collagen, or animal by-products, such as honey or beeswax, have been used in the manufacturing or development of the product. [Am. 4]

Added:(13) To ensure a high level of protection of the aspects of public interest, and to guarantee fair competition on the internal market, economic operators should be responsible for the compliance of detergents or 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.

Added:(14) All economic operators intervening in the supply and distribution chain should take appropriate and effective measures to ensure that they only make available on the Union market detergents and surfactants which are in conformity with this Regulation. It is 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. [Am. 5]

Added:(15) 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 the requirements of 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, Decision No 768/2008/EC specifies that conformity assessment procedures should be chosen from among those modules.

Added:(15a) Manufacturers should keep the technical documentation, the product passport and, where applicable, the digital label for a period of 10 years following the date on which the last item of a batch or model of a detergent or the surfactant covered by that documentation, product passport or digital label has been placed on the market. [Am. 6]

Added:(16) The manufacturer, having detailed knowledge of the design and production process, is best placed to ensure compliance of the detergent or surfactant with the requirements of this Regulation. Manufacturers should therefore be solely responsible for carrying out the conformity assessment procedure for detergents and surfactants. Module A should be applicable for the conformity assessment of detergents and surfactants. Manufacturers should also put together a technical dossier demonstrating compliance of the detergent or surfactant with the relevant rules and test methods.

Added:(17) 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 that manufacturers should be allowed to entrust the authorised representative with. Further, to ensure the enforceability and effectiveness of the market surveillance requirements and that only compliant detergents and surfactants are placed on the Union market, the appointment of an authorised representative should be mandatory when the manufacturer is established outside of the Union. [Am. 7]

Added:(18) With a view to facilitating the communication between economic operators, market surveillance authorities and consumers, economic operators should, as part of their contact details, indicate a website addresstelephone number in addition to the postal addressand email addresses. [Am. 8]

Added:(19) In order to safeguard the functioning of the internal market and to ensure that the objective of providing a high level of protection of health and the environment is achieved, it is necessary to establish that detergents and surfactants from third countries entering the Union market 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 they place on the market comply with those requirements and that the documentation drawn up by manufacturers and, where relevant, the CE marking areis available for inspection by the competent national authorities. Provision should also be made for importers to ensure that a product passport is available for those products. [Am. 9]

Added:(20) 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 their name, registered trade name or registered trade mark as well as their postal and email address and, where available, electronic means of communication telephone number through which they can be contacted. [Am. 10]

Added:(21) As the distributor makes a detergent or surfactant available on the market after it has been placed there by the manufacturer or importer, the distributor should act with due care in relation to the applicable requirements. The distributor should also ensure that its handling of the detergent or surfactant does not adversely affect its compliance with the requirements of this Regulation.

Added:(22) Since distributors and importers 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.

Added:(23) Economic operators that either place a detergent or surfactant on the market under their own name or trade mark 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 assume the obligations of manufacturers. 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 the requirements of this Regulation has not been affected, by indicating their identity on the package and by keeping a copy of the original labelling information.

Added:(24) The CE marking, indicating the conformity of a detergent with this Regulation, is the visible consequence of a whole process comprising conformity assessment in a broad sense. Regulation (EC) No 765/2008 of the European Parliament and of the Council lays down the general principles of the CE marking. That Regulation should be applicable to detergents covered by this Regulation in order to ensure that products benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as health and the environment. In line with Regulation (EC) No 765/2008, the CE marking should be the only marking of conformity indicating that the detergent is in conformity with Union harmonisation legislation. [Am. 11]

Added:(25) To ensure a high level of protection of human health, manufacturers should be required to provide an ingredient data sheet for non-hazardous detergents. In order to optimise efficiency of the relevant requirements and in view of the system related to emergency health response already established under Regulation (EC) No 1272/2008, manufacturers should hold this information at the disposal of poison centres, upon request. [Am. 12]

Added:(26) Labels communicate important use, health and safety information to users, such as the presence of skin or respiratory sensitisers (e.g. allergenic fragrances, preservatives or enzymes) in detergents and surfactants. 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. [Am. 13]

Added:(27) Since the labelling of detergents and surfactants may fall under multiple pieces of Union legislation, the information on detergents' and surfactants’ labels needs to be streamlined so that when similar information stemming from different pieces of Union legislation is required on detergents’ and surfactants’ labels, this information is provided only once in accordance with the stricter rules. This will, on one hand, improve the readability and understandability of detergents’ and surfactants’ labels by end users and, on the other, reduce regulatory burden for detergents’ and surfactants’ manufacturers.

Added:(28) Fragrance substances are organic compounds with characteristic, usually pleasant, odours, which are widely used in detergents but also in many other products such as perfumes and other perfumed cosmetics. Those substances could cause an allergic reaction upon contact, especially to sensitised persons, even when contained in low concentrations. Therefore, it is important to provide information on the presence of individual allergenic fragrances in detergents so that sensitised persons can avoid contact with the substance to which they are allergic. It is therefore necessary to lay down strict requirements for the labelling of allergenic fragrances. However, those substances could also trigger a labelling requirement under Regulation (EC) No 1272/2008. Specific labelling requirements should therefore be established that would apply only when the labelling thresholds under Regulation (EC) No 1272/2008 are not met. This will not only prevent the unnecessary burden for economic operators but also ensure that end-users receive this information presented in a clear manner thus providing a high level of protection of human health even for sensitised persons. Appropriate transition periods should be applied to new labelling requirements established by delegated acts. [Am. 14]

Added:(29) Additional labelling requirements are needed for certain substances such as preservatives in order to ensure a high level of health protection. The labelling requirements for preservatives should, therefore, cover not only those preservatives intentionally added by the manufacturer in the detergent but also those that ensue from its constituent mixtures and which are often referred to as ‘carry-over preservatives’.

Added:(30) 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 and consumer automatic dishwasher detergents in order to prevent the potential over-use of detergents thus reducing the total amount of detergent and surfactant entering the environment.

Added:(31) 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, loud speakers or translation into other languages. Providing 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 information of users. Therefore, economic operators should be allowed to provide certain labelling information only through the digital label subject to certain conditions to ensure a high level of protection of detergents’ users and the environment. [Am. 15]

Added:(31a) Digital labelling could increase readability, ease of use and comprehension of labels for consumers, including vulnerable and visually impaired consumers. [Am. 16]

Added:(32) To avoid imposing an unnecessary administrative burden for economic operators and since, in most cases, the digital label is only complementary to the physical one, economic operators should be able to decide whether to use digital labels or 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 the accurate set of labelling information. [Am. 17]

Added:(33) Digital labelling could also create challenges for the vulnerable population groups with no or insufficient digital skills and lead to an accentuation of the digital divide. For this reason, the specific information to be provided only in a digital label should reflect the current state of the digitalisation of the society and the particular situation of detergents users as well as readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information. In addition, all the labelling information concerning the protection of health and the environment, as well as minimumincluding use instructions of detergents, should remain on the physical label, to enable all end-users to make informed choices before buying the detergent and to ensure its safe handling. [Am. 18]

Added:(34) An exception should, nevertheless, be made For detergents sold to end-users in a refill format. 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, it should be permitted to provideensured that all labelling information digitally with the exception ofis available in a separately available label which should be attached to the packaging at the moment of refill. This should include the dosage instructions for consumer laundry detergents. [Am. 19]

Added:(35) To ensure a level playing field among economic operators making available detergents on the market, and to protect end-users, general requirements for digital labelling should be laid down. For example, economic operators should ensure free and easy access to digital labels, available by way of a maximum two buttons or clicks, and that mandatory labelling information requested under this Regulation is separated from other information. [Am. 20]

Added:(36) Given the current development of the digital skills, economic operators should also provide the labelling information by alternative means to end-users when they cannot access the digital label. This obligation should be imposed as a safety measure to reduce any potential risks by the unavailability of the labelling information, in particular as regards refilled detergents, where all the information may be provided in a digital label. [Am. 21]

Added:(37) Since detergents 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 detergents available on the market in a refill format should ensure that these comply with the same requirements as the pre-packaged ones. In addition, consumers should receive the required labelling information also when opting for refilled detergents. A physical copy of the label should also always be visible at the refill station. The refill sale of detergents should, therefore, be explicitly covered by this Regulation in order to ensure a high level of protection of health and the environment and a level playing field for economic operators. In order to further the Union’s transition towards a circular economy, the reuse and refill of packaging should be encouraged and promoted. Manufacturers and final distributors should, where feasible, enable and further develop the sale of detergents in refill format at the point of sale and should endeavour to make detergents available to consumers in other sustainable sales forms, for example by making detergents available in recyclable packaging that allows consumers to refill the appropriate packaging at home, where possible while ensuring the safety of consumers. [Am. 22]

Added:(38) 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 market surveillance authorities’ task of tracing economic operators who made non-compliant detergents or surfactants available on the market.

Added:(39) Manufacturers should create a product passport to provide information on the conformity of detergents and surfactants with this Regulation, as well as with any other legislation that the detergent or surfactant must comply with. In order to facilitate checks on detergents or surfactants and to allow the actors in the supply chain and end-users to access necessary information such as ingredients and use instructions, the information on the product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the label of the detergent or surfactant, its packaging or the accompanying documentation. Market surveillance authorities, economic operators and end-users should, therefore, have immediate access to compliance or other information on the detergent or surfactant through the data carrier.

Added:(39a) To avoid costs to companies and to the public that are disproportionate to the wider benefits, the product passport should, by default, be specific to the model of a detergent or surfactant. When there are changes to the formula or when there are compositional differences according to the batch, the product passport should be specific to the batch. [Am. 23]

Added:(40) To avoid duplication of investment into digitalisation by all actors involved, including manufacturers, market surveillance authorities and customs authorities, the product passport established under this Regulation should be fully interoperable with the product passport required under other Union legislation.

Added:(41) In particular, Regulation (EU) …/… [of the European Parliament and of the Council establishing a framework for setting ecodesign requirements for sustainable products and repealing Directive 2009/125/EC] also lays down requirements and technical specifications for a digital product passport, the establishment of a Commission central registry where passport information is stored and the interconnection of that registry with the customs IT systems. That Regulation could include detergents or surfactants within its scope in the medium term, thus requiring that a digital product passport is available for them.

Added:(42) The product passport for detergents and surfactants created under this Regulation should therefore comply with the same requirements and technical elements as those set out in Regulation (EU) …/… on ecodesign requirements for sustainable products, including its technical, semantic and organisational aspects of end-to-end communication and data transfer.