Changes from adopted text to adopted text

Removed(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]

Removed(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.

Removed(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.

Removed(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.

Removed(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]

Removed(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]

Removed(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]

Removed(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.

Removed(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]

Removed(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’.

Removed(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.

Removed(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]

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

Removed(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]

Removed(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]

Removed(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]

Removed(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]

Removed(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]

Removed(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]

Removed(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.

Removed(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.

Removed(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]

Removed(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.

Removed(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.

Removed(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.

Removed(43) When other Union legislation applicable to detergents or surfactants requires a product passport, a single product passport should be availablerequired for detergents and surfactants containing the information required under this Regulation and the other Union legislation. Furthermore, the requirements for the technical design of the product passport for detergents and surfactants should be compatible with separate technical design criteria provided for in other Union legislation. [Am. 24]

Removed(44) It is crucial to make clear to both manufacturers and users that by creating the product passport for detergent or surfactant and, where relevant, by affixing the CE marking, the manufacturer declares that the detergent or surfactant is in conformity with all applicable requirements and that the manufacturer takes full responsibility thereof. [Am. 25]

Removed(45) Where certain information is provided only digitally, it is necessary to clarify that this information needs to be provided separately and clearly distinguished from each other but through a single data carrier. This will facilitate the work of market surveillance authorities but also provide clarity to end users regarding the different pieces of information that are available to them in a digital format. [Am. 26]

Removed(46) Chapter VII of Regulation (EU) 2019/1020 of the European Parliament and the Council, setting up the rules of 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, its implementing legislation and the corresponding guidance. This Regulation should therefore not modify in any way Chapter VII of Regulation (EU) 2019/1020 and the way the authorities in charge of controls on products entering the Union market organise themselves and perform their activities.

Removed(47) 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 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.

Removed(48) When detergents and surfactants coming from third countries are presented for release for free circulation, customs should ensure that the reference of a product passport is made available to customs authorities by the economic operator and that this reference corresponds to a unique product identifier that is stored in the product passport registry established by the Commission under [Article 12 of Regulation (EU) …/… on Ecodesign for Sustainable Products]. The interconnection between this registry and the customs IT system as provided for in [Article 13 of Regulation (EU) …/… on ecodesign requirements for sustainable products] should allow for automatic verification of the product passport presented to customs for that detergent or surfactant, so as to ensure that only detergents and surfactants with a valid reference to a unique product identifier as included in the registry are released for free circulation.

Removed(49) Where other information in addition to the unique product identifier and the unique operator identifier is stored in the product passport registry established under [Article 12 of Regulation (EU) …/… on Ecodesign for Sustainable Products], the Commission should be able to provide in a delegated act, that customs authorities are allowed to verify the consistency between this additional information and the information made available by the economic operator to customs, in order to improve the compliance of detergents and surfactants placed under the customs procedure of release for free circulation with this Regulation.

Removed(50) The information included in the product passport may allow customs authorities to enrich and facilitate risk management and enable the better targeting of controls at the Union’s external borders. Therefore, customs authorities should be able to retrieve and use the information included in the product passport and the related registry for carrying out their tasks in accordance with Union legislation including for risk management in accordance with Regulation (EU) No 952/2013.

Removed(51) It is appropriate to provide for the publication of a notice in the Official Journal of the European Union indicating the date when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of Regulation (EU) …/… on Ecodesign for Sustainable Products] becomes operational in order to facilitate public access to that information.

Removed(52) The automatic verification by customs of the product passport reference for detergents and surfactants entering the Union market should not replace or modify the responsibilities of the market surveillance authorities but only 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 information contained in products passports, checks on products within the market and, in case of suspension of release for free circulation by the authorities designated for controls at Union’s external borders, determine the compliance and serious risks of products pursuant to Chapter VII of Regulation (EU) 2019/1020.

Removed(53) Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Union legislation. Regulation (EU) 2019/1020 sets out the framework for market surveillance of products subject to Union harmonisation legislation. Member States should therefore organise and carry out market surveillance of detergents and surfactants in accordance with that Regulation.

Removed(54) Regulation (EU) 2019/1020 already applies to detergents and surfactants, since Regulation (EC) No 648/2004 is listed in its Annex I. However, in order to ensure legal certainty, it is necessary to clarify that rules on internal market surveillance and control of products entering the internal market provided for in Regulation (EU) 2019/1020 also apply to detergents and surfactants covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks. Regulation (EU) 2019/1020 should therefore be amended to include a reference to this Regulation.

Removed(55) Regulation (EC) No 648/2004 provided for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against detergents and surfactants considered to constitute a risk. In order to increase transparency and to reduce processing time, it is necessary to improve the previous safeguard procedure, with the 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 presenting 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 and, given their special and technical nature, acting without the application of Regulation (EU) No 182/2011, determine whether a national measure in respect of a detergent or surfactant presenting a risk is justified.

Removed(56) Experience with Regulation (EC) No 648/2004 has shown that detergents and surfactants which were compliant with the applicable requirements have 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 presenting a risk to health or the environment, even when compliant with the legal requirements. The Commission should, by means of implementing acts and, given their special and technical nature, acting without the application of Regulation (EU) No 182/2011, determine whether a national measure in respect of compliant detergents or surfactants which a Member State finds to pose a risk to health and safety of persons or the environment is justified.

Removed(57) 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 further supplementing the general requirements on digital labelling; amending the labelling information that may be provided in digital format only; amending the limit of the allergenic fragrances when individual risk-based concentration limits for fragrance allergens are established under Regulation (EC) No 1223/2009; 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; and amending Annexes I to VII. The Commission should also be empowered to amend the specific information that should be included in the product passport, as well as the information to be included in the Commission registry. Moreover, the Commission should be empowered to supplement this Regulation by determining the additional information stored in the registry to be controlled by customs authorities. 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 this Regulation by providing an Annex containing a list of Combined Nomenclature codes, as set out in Annex I to Regulation (EEC) No 2658/87, and product descriptions of detergents and surfactants and by updating such Annex.

Removed(58) 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. 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.

Removed(59) 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 product passport for detergents and surfactants. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

Removed(60) In view of the need to ensure a high level 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 in its report assess inter alia if this Regulation is achieving its objectives, taking into account the impacts on small and medium-sized enterprises. [Am. 27]

Removed(61) In order to ensure a high level of protection of health and the environment, foster innovation and boost competitiveness, the Commission should assess the safety requirements for detergents containing micro-organisms and the possibility to allow the use of new micro-organisms or strains of micro-organisms in detergents or to restrict the presence of them, where necessary. [Am. 28]

Removed(61a) In order to facilitate the transition to a fully circular economy, the Commission should assess the introduction of targets for sustainable renewable raw materials and recycled content for detergents. [Am. 29]

Removed(62) This Regulation introduces the possibility of providing all or part of the mandatory labelling requirements only in 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 product passport’s technical requirements. Consequently, the application of this Regulation should be deferred to a date where those preparations can reasonably be finalised.

Removed(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 the date of application of this Regulation without those products having to comply with product requirements laid down by this Regulation. Distributors should therefore be able to supply detergents and surfactants that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of this Regulation.

Removed(64) Transitional arrangements should also be made that allow the placing on the market of detergents and surfactants that at the date of application of this Regulation are not yet in the distribution chain without those products having to comply with the requirements laid down by this Regulation, provided that at the time of their placing on the market they are still compliant with Regulation (EC) No 648/2004. Manufacturers and importers should therefore be able to place on the market detergents and surfactants, namely stock that is not yet in the distribution chain, after the date of application of this Regulation.

Removed(65) Since the objective of this Regulation, namely to guarantee the functioning of the internal market while ensuring that detergents and surfactants on the market fulfil the requirements providing for a high level of protection of health and the environment, cannot be sufficiently achieved by the Member States but can rather, by reason of its 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 that objective,

RemovedHAVE ADOPTED THIS REGULATION:

RemovedCHAPTER I GENERAL PROVISIONS

RemovedArticle 1 Subject matter

Removed1. This Regulation establishes rules for the free movement of detergents and surfactants in the internal market while, at the same time, ensuring a high degree of protection of health and the environment.

Removed2. This Regulation does not affect the application of the following legal acts:

Removed(a) Regulation (EC) No 1907/2006 of the European Parliament and of the Council;

Removed(b) Regulation (EC) No 1272/2008 of the European Parliament and of the Council;

Removed(c) Regulation (EU) No 528/2012 of the European Parliament and of the Council.

RemovedArticle 2 Definitions

RemovedFor the purpose of this Regulation, the following definitions apply:

Removed(1) ‘detergent’ means any of the following: