Changes from report parliamentary committee draft to plenary report

Change 2

RemovedSHORT JUSTIFICATION

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

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

AddedRecital 10: (10) Phosphorus is an ingredient used in detergents. However, phosphorus and its compounds cause significant damage to ecosystems and aquatic environments as they contribute to eutrophication. To further ensure a high level of protection of the environment, and reduce the contribution of detergents to that phenomenon, it is necessary to establish harmonised limits on the content of phosphates and phosphorus compounds in certain consumer and industrial detergents.

AddedRecital 12 a (new): (12a) In accordance with Directive 2010/63/EU of the European Parliament and of the Council1a, it is necessary to replace, reduce or refine testing on animals, with a view to stopping the use of animals for testing as soon as possible. The placing on the market of detergents and surfactants which have been the subject of animal testing in order to meet the requirements of this Regulation should therefore generally be prohibited while still ensuring the protection of human health and allowing the use of historic data. The Commission should validate relevant alternative testing methods and derogations where appropriate and encourage the sharing of information between all relevant stakeholders to support the development of non-animal testing methods taking into account the applicable Union law on the protection of undisclosed business information and on public access to environmental information. / 1a Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33)

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

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.