Changes from report parliamentary committee draft to plenary report

AddedRecital 14: (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.

AddedRecital 15 a (new): (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.

AddedRecital 17: (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.

AddedRecital 18: (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 telephone number in addition to the postal and email addresses.

AddedRecital 19: (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 is 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.

AddedRecital 20: (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 telephone number through which they can be contacted.

AddedRecital 24: deleted / (deleted)

AddedRecital 25: (25) To ensure a high level of protection of 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.

AddedRecital 26: (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.

AddedRecital 28: (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.

AddedRecital 31: (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 through the digital label subject to certain conditions to ensure a high level of protection of detergents’ users and the environment.

AddedRecital 31 a (new): (31a) Digital labelling could increase readability, ease of use and comprehension of labels for consumers, including vulnerable and visually impaired consumers.

AddedRecital 32: (32) To avoid imposing an unnecessary administrative burden for 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 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.

AddedRecital 33: (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 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, including 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.

AddedRecital 34: (34) For detergents sold to end-users in a refill format, it should be ensured that all labelling information is 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.

AddedRecital 35: (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.

AddedRecital 36: (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.

AddedRecital 37: (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.

AddedRecital 39 a (new): (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.

AddedRecital 43: (43) When other Union legislation applicable to detergents or surfactants requires a product passport, a single product passport should be required 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.

AddedRecital 44: (44) It is crucial to make clear to both manufacturers and users that by creating the product passport for detergent or surfactant, the manufacturer declares that the detergent or surfactant is in conformity with all applicable requirements and that the manufacturer takes full responsibility thereof.

AddedRecital 45: (45) Where certain information is provided 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.

AddedRecital 60: (60) In view of the need to ensure a high level of 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.

AddedRecital 61: (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.

AddedRecital 61 a (new): (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.

AddedArticle 2 – paragraph 1 – point 1 – indent 3: – a mixture intended to modify the feel or odour of fabrics in processes which are to complement the washing of fabrics;

AddedArticle 2 – paragraph 1 – point 3 a (new): (3a) ‘hard surface cleaning product’ means any all-purpose cleaner, kitchen cleaner, window cleaner or sanitary;

AddedArticle 2 – paragraph 1 – point 3 b (new): (3b) ‘consumer hand dishwashing detergent’ means a detergent used for the cleaning of dishes, cutlery and other kitchen utensils by hand, which is placed on the market for use by non-professionals;

AddedArticle 2 – paragraph 1 – point 3 c (new): (3c) ‘industrial and institutional laundry detergent’ means a detergent for laundry placed on the market for use by specialised personnel outside the domestic sphere;

AddedArticle 2 – paragraph 1 – point 3 d (new): (3d) ‘industrial and institutional dishwasher detergent’ means a detergent placed on the market for use by specialised personnel in automatic dishwashers outside of the domestic sphere.

AddedArticle 2 – paragraph 1 – point 6: (6) ‘cleaning’ means the process by which an undesirable deposit is dislodged from a substrate or from within a substrate and brought into a state of solution or dispersion, including by using micro-organisms;

AddedArticle 2 – paragraph 1 – point 20: (20) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in in this Regulation and other applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation;

AddedArticle 2 – paragraph 1 – point 21: (21) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point 4, of Regulation (EU) 2019/1020 as responsible for organising and carrying out market surveillance in the territory of that Member State;

AddedArticle 2 – paragraph 1 – point 24: deleted

AddedArticle 2 – paragraph 1 – point 25: (25) ‘corrective action’ means an action as defined in Article 3, point 16, of Regulation (EU) 2019/10201a; / 1a Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

AddedArticle 2 – paragraph 1 – point 28: (28) ‘unique product identifier’ means a unique string of characters for the identification of a product that also enables a web link to the product passport;

AddedArticle 2 – paragraph 1 – point 29: (29) ‘unique operator identifier’ means a unique string of characters for the identification of actors involved in the value chain of products;

AddedArticle 2 – paragraph 1 – point 33: (33) ‘refill’ means the operation by which a consumer or a professional user fills a packaging with a detergent offered by a supplier in the course of a commercial activity, whether in return for payment or free of charge;

AddedArticle 2 – paragraph 1 – point 34 a (new): (34a) ‘model’ means a group of detergents or surfactants that meet the following conditions: / - they are under the responsibility of the same manufacturer; / - they have the same content, in accordance with Part A of Annex V, and are manufactured using the same manufacturing processes; / - they are intended to have a uniform composition when tested in accordance with the same test methods; and / - they are clearly defined by a type number or other element allowing their identification;

AddedArticle 4 – paragraph 2 – introductory part: 2. Paragraph 1 shall not apply to surfactants that are active substances, as defined in Article 3(1), point (c), of Regulation (EU) No 528/2012, and that are used as disinfectants when they meet any of the following conditions:

AddedArticle 4 – paragraph 2 – point a – introductory part: (a) they are included in the Union list of approved active substances as laid down in Article 9(2) of Regulation (EU) No 528/2012;

AddedArticle 4 – paragraph 2 – point a – point i: deleted

AddedArticle 4 – paragraph 2 – point a – point ii: deleted / (deleted)

AddedArticle 4 – paragraph 2 – point b: (b) they are included in the review programme as set out in Commission Delegated Regulation (EU) No 1062/20141a; / 1a Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

AddedArticle 4 – paragraph 2 – point c: (c) they are constituents of biocidal products and may be made available on the market or used in accordance with Article 55 of Regulation (EU) No 528/2012.

AddedArticle 4 – paragraph 2 a (new): 2a. By... [4 years from the entry into force of the delegated act adopted in accordance with the second subparagraph] organic ingredients of detergents other than surfactants shall be inherently biodegradable. / By… [two years from the date of entry into force of this Regulation], the Commission shall adopt delegated acts in accordance with Article 27 to supplement Annex I with inherent biodegradability criteria and test methods for constituents other than surfactants. / Where necessary, the Commission is empowered to adopt delegated acts in accordance with Article 27 to allow for the use of substances in detergents that do not comply with the biodegradability criteria established in accordance with Annex I. / When adopting delegated acts in accordance with the second and third subparagraphs, the Commission shall take into account manufacturing practices, the availability of technically and economically feasible alternatives, the impact on small and medium-sized enterprises and the impact on health and environment.

AddedArticle 4 – paragraph 2 b (new): 2b. By... [two years from the entry into force of the delegated act adopted in accordance with the second subparagraph], water-soluble film around detergents shall be degradable. / By… [18 months from the date of entry into force of this Regulation], the Commission shall adopt delegated acts in accordance with Article 27 supplementing Annex I with criteria and test methods for the degradability of water-soluble film around detergents.

AddedArticle 6 – paragraph 1 a (new): The first paragraph shall not apply to detergents that are industrial biocidal products within the meaning of Regulation (EU) No 528/2012 or medical devices within the meaning of Regulation (EU) No 2017/7451a. / 1a Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

AddedArticle 6 – paragraph 1 b (new): The unintentional presence in surfactants and detergents of phosphates and other phosphorus compounds that stems from impurities of ingredients, from the manufacturing process or storage or from migration from packaging, shall be tolerated if that presence is technically unavoidable in good manufacturing practice and, notwithstanding such presence, those surfactants and detergents are safe.

AddedArticle 6 a (new): Article 6a / Animal testing / 1. The safety of detergents and surfactants and conformity with this Regulation shall be established by using non-animal new approach methods validated and adopted at Union level. / 2. Without prejudice to the general obligations pursuant to Article 1(1), the following shall be prohibited: / (a) the placing on the market of detergents and surfactants where the final formulation or ingredients or combinations of ingredients have been the object of animal testing with a view to meeting the requirements of this Regulation; / (b) the performance within the Union of animal testing of finished detergents and surfactants or ingredients or combinations of ingredients with a view to meeting the requirements of this Regulation. / 3. Paragraphs 1 and 2 shall be applicable without prejudice to relevant Union law, and shall not prevent the use of data acquired before .... [the date of entry into force of this Regulation]. / 4. In exceptional circumstances, where concerns arise as regards the safety of a detergent ingredient, the Commission may adopt a decision granting a derogation from paragraphs 1 and 2. The Commission may act on its own initiative or on the basis of a reasoned request from an economic operator or a Member State. / When the Commission acts on the basis of a reasoned request from an economic operator or a Member State, that request shall contain an evaluation of the situation and indicate the necessary measures. On that basis, the Commission…

AddedArticle 7 – paragraph 2 – subparagraph 2 – point c: deleted

AddedArticle 7 – paragraph 3: 3. Manufacturers shall keep and, where necessary, update the technical documentation and the product passport for 10 years after the detergent or the surfactant covered by that documentation or product passport has been placed on the market.

AddedArticle 7 – paragraph 6 – subparagraph 2 – point a: (a) at the time of placing a detergent on the market;

AddedArticle 7 – paragraph 6 – subparagraph 2 – point b: (b) when the detergent for which a data sheet has already been provided no longer corresponds to the information included in that datasheet.

AddedArticle 7 – paragraph 7: 7. Manufacturers that consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective actions necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where manufacturers consider or have reason to believe that a detergent or surfactant which they have placed on the market presents a risk to health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective actions taken.

AddedArticle 7 – paragraph 7 a (new): 7a. Manufacturers shall, upon request, share relevant information in a timely manner with relevant economic operators, including distributors, importers and authorised representatives, in the supply chain concerned on any conformity issue or risk to health or the environment that they have identified in relation to their product, and of any consequent corrective action, recall or withdrawal.

AddedArticle 7 – paragraph 8: 8. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in electronic format and, on request, in paper format, necessary to demonstrate the conformity of the detergent or surfactant with this Regulation, in a language which can be easily understood by that authority. The relevant information and documentation shall be provided within 20 working days of receipt of the request. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by a detergent or surfactant which they have placed on the market.

AddedArticle 7 – paragraph 8 a (new): 8a. Manufacturers shall make their communication channels, such as a telephone number, an email address or a dedicated section of their website, publicly available on their website, taking into account the accessibility needs of persons with disabilities and enabling end-users to submit complaints or concerns about potential non-conformity of products or safety issues

AddedArticle 8 – paragraph 1: 1. Manufacturers may, by a written mandate, appoint an authorised representative. The authorised representative’s mandate shall be valid only when accepted in writing by the authorised representative.

AddedArticle 8 – paragraph 2 a (new): 2a. Manufacturers that are not established in the Union, shall inform the national competent authorities of the postal address and e-mail address of their authorised representative.

AddedArticle 8 – paragraph 3 – subparagraph 1: An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall have the appropriate means to perform the tasks specified in the mandate. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.

AddedArticle 8 – paragraph 3 – subparagraph 2 – point c: (c) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the detergent or surfactant with the requirements laid down in this Regulation, within 20 working days of the receipt of the request and in a language that can be easily understood by that authority;

AddedArticle 8 – paragraph 3 – subparagraph 2 – point e: (e) terminate the mandate if the manufacturer does not comply with the obligations of the manufacturer under this Regulation and inform, within 20 working days, the market surveillance authority of the Member State in which the manufacturer is established of the termination of the mandate.

AddedArticle 8 – paragraph 3 – subparagraph 2 – point e a (new): (ea) where the authorised representative considers or has reason to believe that a detergent or a surfactant presents a risk to health or to the environment, inform the manufacturer thereof;

AddedArticle 8 – paragraph 3 a (new): 3a. When the authorised representative changes, detailed arrangements related to that change shall be laid down in a mandate in accordance with paragraphs 1, 2, and 3.

AddedArticle 9 – paragraph 2 – point b: deleted

AddedArticle 9 – paragraph 4: 4. Importers shall indicate their name, registered trade name or registered trade mark, the postal and email address and telephone number at which they can be contacted on the label of the detergent or surfactant. The contact details shall be in a language easily understood by end-users and market surveillance authorities and shall be clear, understandable and legible.

AddedArticle 9 – paragraph 8: 8. Importers that consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in conformity with this Regulation shall immediately inform and cooperate with the manufacturer and the competent authorities and shall immediately take the corrective actions necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where importers consider or have reason to believe that a detergent or surfactant which they have placed on the market presents a risk to health or the environment, they shall immediately inform the manufacturer and the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective action taken.

AddedArticle 9 – paragraph 8 a (new): 8a. Importers shall, upon request from market surveillance authorities, share in a timely manner relevant information with relevant economic operators, including distributors and authorised representatives, in the supply chain concerned as regards any conformity issue or risk to health or the environment that they have identified in relation to their product, and of any consequent corrective action, recall or withdrawal.

AddedArticle 9 – paragraph 10: 10. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in electronic format and, on request, in paper format, necessary to demonstrate the conformity of the detergent or surfactant with this Regulation in a language which can be easily understood by that authority. The relevant information and documentation shall be provided within 20 working days of receipt of the request. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by a detergent or surfactant which they have placed on the market.

AddedArticle 9 – paragraph 10 a (new): 10a. Importers shall verify whether the communication channels referred to in Article 7(8a) are publicly available to consumers, thereby allowing consumers to submit complaints and concerns about potential non-conformity of products. Where such channels are not available, importers shall provide for such channels, taking into account accessibility needs for persons with disabilities.

AddedArticle 10 – paragraph 2 – point b: deleted

AddedArticle 10 – paragraph 5: 5. Distributors that consider or have reason to believe that a detergent or a surfactant which they have made available on the market is not in conformity with this Regulation shall immediately inform and cooperate with the manufacturer or importer, as applicable, and the competent authorities and shall ensure that the corrective actions necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where distributors consider or have reason to believe that a detergent or surfactant which they have made available on the market presents a risk to health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective action taken.

AddedArticle 10 – paragraph 6: 6. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in electronic format and, on request, in paper format, necessary to demonstrate the conformity of the detergent or surfactant with this Regulation. The relevant information and documentation shall be provided within 20 working days of receipt of the request. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by detergents and surfactants which they have made available on the market.

AddedArticle 12 – paragraph 1 – point a: (a) to ensure that the package bears his or her name, registered trade name or registered trade mark, postal and email address and telephone number at which they can be contacted preceded by the words ‘packaged by’ or ‘repackaged by’;

AddedArticle 14: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

AddedArticle 15 – paragraph 2: 2. An economic operator making a detergent available on the market directly to an end-user in a refill format shall provide the physical label and the data carrier through which the digital label is accessible to the end-user.

AddedArticle 15 – paragraph 3 – subparagraph 1 – point a: (a) a type number, model number, batch number or other element allowing their identification;

AddedArticle 15 – paragraph 3 – subparagraph 1 – point b: (b) the manufacturer’s name and, where relevant, the manufacturer’s authorised representative’s name, registered trade name or registered trade mark, the postal and email address and telephone number at which they can be contacted. The postal address shall indicate a single point at which the manufacturer can be contacted;

AddedArticle 15 – paragraph 5: 5. The information referred to in paragraphs 3 and 4 shall be in a language which can be easily understood by end-users, as determined by the Member State concerned, and shall be clear, understandable and intelligible and shall comply with the requirements set out in Section 1.2.1.4 and 1.2.1.5 of Part 1 of Annex I to Regulation (EC) No 1272/2008. The label shall be accessible for inspection purposes where the detergent or surfactant is made available on the market.

AddedArticle 15 – paragraph 5 a (new): 5a. Without prejudice to Directive .../… [Directive of the European Parliament and of the Council on substantiation and communication of explicit environmental claims (Green Claims Directive)COM/2023/166 final], the label of detergents and surfactants may report the fact that no animal tests have been carried out only if the manufacturer and its suppliers, where this information can be identified by the manufacturer with all reasonable efforts, have not carried out or commissioned any animal tests on the finished detergent or surfactant, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others for the purpose of developing new detergents or surfactants. The label may only report the fact that the detergent or surfactant is ‘vegan’ or ‘animal-free’ if no animal-derived ingredients or animal by-products have been used in the production and development of the detergent or surfactant.

AddedArticle 16 – paragraph 1 – subparagraph 1 – point a: (a) on a physical label or;

AddedArticle 16 – paragraph 1 – subparagraph 2: Where the dosage information for consumer laundry detergents in accordance with points 1 and 2 of part B of Annex V is provided on the digital label, a simplified dosage grid as set out in part D of Annex V may be provided on the physical label.

AddedArticle 16 – paragraph 2: 2. Where detergents are made available on the market directly to an end-user in a refill format, the operator shall ensure that the label elements set out in Article 15(2), (3) and (4) are affixed to the packaging.

AddedArticle 17 – paragraph 1 – point b: (b) the information on the digital label shall be easily searchable;

AddedArticle 17 – paragraph 1 – point e: (e) the information on the digital label shall be presented in a format that 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;

AddedArticle 17 – paragraph 1 – point i: (i) the information on the digital label shall be easily accessible via the data carrier.

AddedArticle 17 – paragraph 2 – subparagraph 1: The data carrier shall be physically, indelibly, visibly and legibly present on the detergent or surfactant, their packaging or the documentation accompanying them, in a way that allows it to be processed automatically by digital devices.

AddedArticle 17 – paragraph 3: 3. Where economic operators provide a digital label, the data carrier shall be accompanied by the statement ‘Please scan for more comprehensive information on the product’ or by a similar statement.

AddedArticle 17 – paragraph 4: 4. Economic operators shall not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the information on the digital label online.

AddedArticle 17 – paragraph 5 – subparagraph 1 – introductory part: Economic operators shall provide the information present in the digital label by other means and free of charge in any of the following cases:

AddedArticle 18 – paragraph 1 – subparagraph 1 a (new): This obligation shall apply 18 months from the entry into force of the implementing act adopted in accordance with paragraph 9.

AddedArticle 18 – paragraph 2 – point a: (a) it shall correspond to a specific model, that shall be updated when changes are made to the list of ingredients, or where appropriate, to a specific batch of the detergent or surfactant;

AddedArticle 18 – paragraph 2 – point d: (d) it shall be up-to-date, accurate and complete;

AddedArticle 18 – paragraph 2 – point f: (f) it shall be easily accessible to customers, end-users, manufacturers, importers, distributors, competent national authorities, market surveillance authorities, customs authorities, the Commission, other economic operators and other relevant stakeholders, such as civil society organisations and researchers;

AddedArticle 18 – paragraph 2 – point i: (i) it shall fulfil the specific and technical requirements laid down pursuant to paragraph 9.

AddedArticle 18 – paragraph 3 – subparagraph 1: The data carrier shall be physically present on the detergent or surfactant, their packaging or the documentation accompanying them, in accordance with the implementing act referred to in paragraph 9.

AddedArticle 18 – paragraph 3 – subparagraph 3: The data carrier shall be clearly visible to the end-user before any purchase and to market surveillance authorities, including, where applicable, in cases where the detergent or surfactant is made available through distance sales on the main page of the online product page.

AddedArticle 18 – paragraph 9 – subparagraph 1 – introductory part: By ... [12 months from the entry into force of this Regulation], the Commission shall adopt an implementing act determining the specific and technical requirements related to the product passport for detergents and surfactants. Those requirements shall set out at least the following:

AddedArticle 19 – paragraph 1 – point b: (b) all information included in the product passport shall be based on open standards developed with an interoperable format and shall be, where appropriate, machine readable, structured, searchable, and transferable through an open interoperable data exchange network without vender lock-in;

AddedArticle 19 – paragraph 1 – point b a (new): (ba) product passports shall be designed and operated in a user-friendly way;

AddedArticle 19 – paragraph 1 – point c: (c) end-users, economic operators and other relevant actors shall have easy access to the product passport free of charge and without restricting access to existing users;

AddedArticle 19 – paragraph 1 – point d: (d) the data included in the product passport shall be stored and updated by the economic operator responsible for its creation or by operators authorised to act on their behalf;

AddedArticle 22 – paragraph 1: 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a detergent or surfactant presents a risk to health, safety or the environment, they shall carry out an evaluation in relation to the detergent or surfactant concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

AddedArticle 22 – paragraph 3: 3. Where, in the course of the controls referred to in paragraph 1 or paragraph 2, the market surveillance authorities find that the detergent or surfactant does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operators to take all appropriate corrective action to bring the detergent or surfactant into compliance with those requirements, to withdraw it from the market, or to recall it within a reasonable period laid down by the market surveillance authorities and which is commensurate with the nature of the risk referred to in paragraph 1.

AddedArticle 24 – paragraph 1: 1. Where, having carried out an evaluation under Article 22(1), a market surveillance authority finds that although a detergent or surfactant is in compliance with this Regulation, it presents a risk to health or to the environment, it shall require the relevant economic operator to take all appropriate measures to ensure that the detergent or surfactant concerned, when placed on the market, no longer presents that risk, to withdraw the detergent or surfactant from the market or to recall it, within a reasonable period laid down by the market surveillance authorities and which is commensurate with the nature of that risk.

AddedArticle 24 – paragraph 4 – subparagraph 2 a (new): On duly justified imperative grounds of urgency relating to the protection of health or the environment, the Commission shall adopt an implementing act, in accordance with the procedure referred to in Article 28(2a), and ensure that such implementing act is immediately applicable.

AddedArticle 25 – paragraph 1 – point a: deleted

AddedArticle 25 – paragraph 1 – point e a (new): (ea) any other administrative obligation provided for in this Regulation is not fulfilled.

AddedArticle 26 – paragraph 1: 1. The Commission is empowered to adopt delegated acts in accordance with Article 27 amending Annex VI, as regards the information to be provided in the product passport, for the purposes of adapting it to technical and scientific progress and to the level of digital readiness of market surveillance authorities and of end-users, taking into account the applicable Union law on the protection of undisclosed business information and on public access to environmental information.

AddedArticle 26 – paragraph 6 a (new): 6a. Where Commission Regulation (EC) 440/20081aprovides for non-animal approaches for testing the respiratory sensitisation properties of micro-organisms, the Commission shall, without undue delay, adopt delegated acts in accordance with Article 27 to amend Annex II to this Regulation by determining the requirements for placing on the market detergents containing micro-organisms in a spray format. / 1a Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/440/oj).

AddedArticle 26 – paragraph 6 b (new): 6b. The Commission is empowered to adopt delegated acts in accordance with Article 27 to amend Annex II by updating the standards applicable for the enumeration of micro-organisms to take into account scientific and technical progress.

AddedArticle 28 – paragraph 2 a (new): 2a. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/20111a, in conjunction with Article 5 thereof, shall apply. / 1a Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

AddedArticle 29 – paragraph 1: Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. They may include, where appropriate, financial penalties proportionate to the turnover of the legal person that committed the infringement, taking into account the specificities of small and medium-sized enterprises. Member States shall, without delay, notify the Commission of those measures and of any subsequent amendment affecting them.

AddedArticle 29 – paragraph 1 a (new): Member States shall ensure that the penalties established pursuant to this Article give due regard to the following, where applicable: / (a) the nature, gravity, and extent of the infringement; / (b) the intentional or negligent character of the infringement; / (c) the damage to human health or the environment caused by the infringement, insofar as it can be determined; / (d) the level of cooperation of the natural or legal person held responsible with the competent authority.

AddedArticle 31 – paragraph 1: By [OP: please insert the date = 5 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of: / (a) how this Regulation is achieving its objectives, including an assessment on the impact on small and medium-sized enterprises; / (b) the risk of the generation of anti-microbial resistance associated with the use of detergents or surfactants with biocidal properties; / (c) the occurrence of unsubstantiated marketing claims, advertisements and packaging designs which mislead or have the potential to mislead consumers by giving the impression of healthier or environmentally friendlier detergents or surfactants; / (d) physical and digital labelling requirements of detergents, taking into account the safety of end-users and the environment and the level of digital readiness among all population groups in the Union. / (e) the feasibility and environmental and socio-economic costs and benefits of a phase out of phosphorus in consumer detergents and of a reduction and where possible phase-out of phosphorus in detergents for industrial & institutional use in line with the commitments under the Baltic Sea Action Plan; / (f) the environmental, health and socio-economic costs and benefits of extending the generic approach to risk management to detergents and surfactants and of phasing out substances of concern, including those tha…

AddedArticle 32 – paragraph 1: By [OP: please insert the date = 3 years from the date of application of this Regulation], the Commission shall assess the effectiveness and relevance of the requirements of this Regulation for detergents containing micro-organisms, in particular the list of pathogenic micro-organisms provided for in point 2 of Annex II and the effects of micro-organisms intentionally added to detergents on urban wastewater treatment processes, as well as the possibility to include new micro-organisms or strains of micro-organisms allowed in detergents in Annex II.

AddedArticle 32 – paragraph 1 a (new): By ... [OP: please insert the date = 3 years from the date of application of this Regulation] and every 3 years thereafter, the Commission shall review the list of pathogenic micro-organisms provided for in point 2 of Annex II and, where necessary, adopt delegated acts in accordance with Article 27 to amend Annex II in order to take into account scientific and technical progress.

AddedArticle 32 a (new): Article 32a / Renewable feedstock content review / By ... [OP: please insert date – 3 years from the date of application of this Regulation], the Commission shall submit a report to the European Parliament and to the Council assessing the necessity, feasibility, technical consequences and benefits for health and the environment of the introduction of mandatory targets for renewable raw materials and recycled content in detergents and surfactants. In that report, the Commission shall specifically take into account socio-economic impacts, competitiveness of economic operators in the Union, sustainable sourcing as well as the global warming potential, the potential for using food waste in detergents and the potential land use change associated with alternative feedstock and food security in the Union. The report shall be accompanied, where appropriate, by a legislative proposal.

AddedAnnex II – point 1 – subparagraph 1 – point a: (a) shall belong to a collection of an International Depository Authority (IDA) or have had their DNA identified in accordance with a “Strain identification protocol” (using 16S ribosomal DNA sequencing or an equivalent method) ;

AddedAnnex II – point 2 – point e a (new): (ea) Pseudomonas aeruginosa, test method ISO 22717:2015;

AddedAnnex II – point 2 – point e b (new): (eb) Candida albicans, test method ISO 18416:2015;

AddedAnnex II – point 2 – point e c (new): (ec) any other micro-organisms listed in Annex 1, Table 4 of Regulation (EU) 2020/7411a. / 1a Regulation (EU) 2020/741 of the European Parliament and of the Council of 25 May 2020 on minimum requirements for water reuse (OJ L 177, 5.6.2020, p. 32, ELI: http://data.europa.eu/eli/reg/2020/741/oj).

AddedAnnex II – point 5: 5. When placed on the market, detergents containing micro-organisms shall have a standard plate count equal to or greater than 1x105 colony-forming units (CFUs) per ml in accordance with ISO 21149 or ISO 4833-1:2014.

AddedAnnex II – point 6: 6. The minimum shelf life of a detergent containing micro-organisms shall not be lower than 24 months and the microbial count shall not decrease by more than 10 % every 12 months in accordance with ISO 21149 or ISO 4833-1:2014.

AddedAnnex II – point 7: 7. Detergents containing micro-organisms shall be allowed to be placed on the market in a spray format after appropriate non-animal approaches to testing the respiratory sensitisation properties of micro-organisms have been established in accordance with Article 26(6a).

AddedAnnex II – point 9: 9. The manufacturer shall substantiate all claims made regarding the actions or performance of the micro-organisms contained in the product with appropriate tests. Those tests shall be verified by an independent third party.

AddedAnnex V – Part A – point 1 – point c: (c) surfactants,

AddedAnnex V – Part A – point 1 – point d: deleted

AddedAnnex V – Part A – point 1 – point e: deleted

AddedAnnex V – Part A – point 1 – point f: deleted

AddedAnnex V – Part A – point 3 – subparagraph 2 a (new): Where a digital label is provided in accordance with Article 16(1) of this Regulation, the preservatives shall be listed, using where possible the system referred to in Article 33 of Regulation (EC) No 1223/2009, irrespective of their concentration.

AddedAnnex V – Part B – point 1 – point a: (a) the recommended quantities and/or dosage instructions expressed in millilitres or grams or, where relevant, number of units appropriate to a standard washing machine load, for soft, medium and hard water hardness levels and making provision for one or two cycle washing processes,

AddedAnnex V – Part B – point 1 – point c: (c) the capacity of any measuring cup, if provided, shall be indicated in millilitres or grams, and clearly visible markings shall be provided that significantly contrast the colour of the measuring cup to indicate the dose of detergent appropriate for a standard washing machine load for soft, medium and hard water hardness levels,

AddedAnnex V – Part B – point 1 – point c a (new): (ca) for detergents packed in bottles, the dose of detergent appropriate for a standard washing machine load at least for soft and medium water hardness level shall be provided by clearly visible markings on the lid, that significantly contrast the colour of the lid.

AddedAnnex V – Part B – point 3: 3. The label of consumer automatic dishwasher detergents shall indicate the standard dosage expressed in grams or millilitres or number of units for the main washing cycle for normally soiled tableware in a fully loaded 12 place settings dishwasher, adjusting the standard dosage, where relevant, for soft, medium, and hard water hardness.

AddedAnnex V – Part C: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

AddedAnnex V – Part D – paragraph 1 – point b: (b) the recommended quantities based on medium water hardness and different degrees of fabric soiling; and

AddedAnnex V – Part D – paragraph 1 – subparagraph 1 a (new): Points (1)(c) and (d) of Part B shall also apply where the simplified dosage information is provided.

AddedAnnex VI – paragraph 1 – point b: (b) the name, the postal and email address of the manufacturer or the manufacturer’s authorised representative as well the manufacturer’s unique operator identifier;

AddedAnnex VI – paragraph 1 – point f: (f) a full list of substances intentionally added in the detergent or surfactant and of preservatives, using the International Nomenclature of Cosmetic Ingredients, or where it is not available, the common chemical name or International Union of Pure and Applied Chemists name.

AddedAnnex VI – paragraph 1 – point f a (new): (fa) the technical documentation and results of the conformity assessment procedure referred to in Article 7(2);

AddedAnnex VI – paragraph 1 – point f b (new): (fb) where applicable, the results of the test carried out by the manufacturer in accordance with point 9 of Annex II and the third party verification statement of those tests;

AddedAnnex VI – paragraph 1 – point f c (new): (fc) where applicable, a link to the digital label referred to in Article 16(1).

AddedAnnex VI – paragraph 2 a (new): The information referred to in point (fa) shall only be available to market surveillance authorities of the Member States and the Commission.

AddedAs an essential product of every-day use, the detergents sector is a key pillar for the implementation of the European Green Deal. The manufacturing of detergents secures jobs in Europe and provides consumers with high-quality products. Many companies have already shown that there can be a market for innovative, safe, clean, sustainable and circular products. However, today, market forces and policies do not provide sufficient support for these European frontrunners. There is an obvious and urgent need for more innovation and competition in sustainable detergents in Europe. The Detergents Regulation has so far failed to address this need.

AddedTherefore the Rapporteur welcomes the proposal by the European Commission for a revision for more innovation, as the inclusion of microbial cleaning products in the scope of the Regulation and the streamlining of information requirements for clearer consumer information, in particular with respect to overlaps with other Union legislation. The Rapporteur also welcomes the proposal for the refill sale of detergents in order to reduce the amount of packaging placed on the market.

AddedHowever, the Rapporteur also finds that further measures are needed to reach the objectives of the protection of consumers, the environment and animals as well as a European climate neutral, toxic-free and safe circular economy. To this end, the Rapporteur proposes a number of amendments in order to create new opportunities to promote sustainability and increase competition and innovation in sustainable detergents on the European market.

AddedBiodegradability of detergents

AddedWith regard to the objective of protecting health and the environment, full biodegradability is the most effective option in the toolbox of the Detergents Regulation. Currently, detergents may contain various substances that are hazardous and persistent in the environment, posing potential risks to ecosystems and animal and human health. While the rapporteur appreciates that certain derogations have been removed from biodegradability criteria, the Commission’s proposal falls short of providing for all detergents to be fully biodegradable. The rapporteur therefore proposes to make all detergents inherently biodegradable, as large European manufacturers have already committed to achieve this. European legislation should not fall behind, but should instead provide incentives for other manufacturers to follow suit and to provide for a level playing field.

AddedPhosphates and phosphorus content

AddedPhosphates are a main contributor to the widespread problem of eutrophication across Europe. Municipalities across Europe are investing heavily in downstream solutions to clean wastewater of phosphates. These efforts should be helped by avoiding phosphate emissions into wastewater upstream, where possible. Similarly to the biodegradability requirements, industry is already advancing ahead of European legislation. There are numerous examples of manufacturers that have phased out phosphates in consumer and industrial products a long time ago. In order to further foster innovation in the sector, the thresholds for total phosphorus content in consumer products should be strengthened. Equally, there should be limits for certain industrial products, where current technologies already allow manufacturers to use products with little or no phosphate and other phosphorus substances.

AddedHazardous substances

AddedThe Commission’s Chemicals Strategy for Sustainability clearly spelled out a goal of safe and sustainable products for a toxic-free environment. It provided for concrete measures to tackle the most hazardous substances in consumer products. In particular, the Strategy establishes that the generic approach to risk management will be extended to ensure that consumer products – including, among other things, detergents – do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative.

AddedThe Chemicals Strategy was widely welcomed by stakeholders including industry and civil society and the European Parliament. The Parliament has on numerous occasions asked for stricter protection of consumers from hazardous chemicals. The rapporteur therefore proposes to implement the Chemicals Strategy in the Detergents Regulation by prohibiting the use of certain hazardous substances, unless they are technically necessary.

AddedBetter consumer information

AddedThe rapporteur believes citizens should be able to make informed decisions while purchasing a product. Therefore products should bear legible, clear and easily understandable labels with the most important information directly on the product. The same should apply to refill products. The proposal by the Commission would need to be amended to ensure consumers are informed of all ingredients, and in particular allergenic substances in physical form, with digital labels providing additional information where necessary.

AddedThe environmental impact of detergents grows with the amount of detergents consumed. It is therefore important to avoid overconsumption, a key driver of allergies and pollution of this sector. It should be made easier for consumers to use the right dosage, in particular for laundry detergents. The simplification proposed by the Commission is a good first step, but in order to improve consumer information the rapporteur envisages much clearer and better visible measuring indications on the lid of the product and measuring device.

AddedOnly supplementary information should be available in a digital format only. The digital option should only be seen as a complementary tool and never as the only tool to enable informed consumer choice.

AddedAnimal Testing

AddedThe rapporteur strongly believes that it is essential to phase out unnecessary animal testing and as almost a million and a half Europeans have requested in the recent “European Citizens initiative to end animal testing in cosmetics”, to turn towards non-animal approaches to assure the safety of products. In addition, in 2021 the European Parliament voted a Joint Motion for a Resolution on plans and actions to accelerate the transition to innovation without the use of animals in research, regulatory testing and education.

AddedTherefore, the proposal of the Commission to mandate animal testing for acute toxicity for detergents containing microorganisms is clearly against the position not only of our citizens, but also of industry stakeholders that clearly oppose the demand for animal testing on microorganisms used in spray form as unnecessary. This is also in conflict with the animal protection commitments of industry and European legislators, considering that the Commission has on multiple occasions expressed its commitment to use animal testing as a last resort.

AddedMoreover, in vivo tests are not suitable for determining the risk to consumers of inhaling aerosols containing micro-organisms and would be an unnecessary use of animals. Consequently, the acute inhalation toxicity test for microbial cleaner sprays should be able to be replaced by alternative new approach methodologies (NAMs), which are more appropriate methods to address potential safety concerns. Such alternative risk-based approaches use benchmarks known to be safe for consumers based on data derived from human data and therefore better reflect the impact on humans directly.

AddedAlignment with ESPR

AddedWherever possible, the rapporteur aims to align the provisions of the Detergents Regulation with other relevant EU legislation. In particular the ongoing negotiations on the Ecodesign for Sustainable Products Regulation have served as a basis for amendments to the Digital Product Passport in order to ensure full interoperability between different pieces of legislation.

Added24.1.2024