Changes from adopted text to adopted text

Removed(a) surfactants that arethey are included in the Union list of approved active substances within the meaning ofas laid down in Article 3(1), point (c),9(2) of Regulation (EU) No 528/2012 and that are used as disinfectants where they meet any of the following conditions:; [Am. 45]

Removed(i) the surfactants are included in the Union list of approved active substances as laid down in Article 9(2) of Regulation (EU) No 528/2012; [Am. 46]

Removed(ii) the surfactants are included in the review programme as set out in Commission Delegated Regulation (EU) No 1062/2014; [Am. 47]

Removed(b) surfactants that are constituents of biocidal products authorised in accordance withthey are included in the review programme as set out in Commission Delegated Regulation (EU) No 528/2012No 1062/2014; [Am. 48]

Removed(c) surfactants thatthey are constituents of biocidal products and which may be made available on the market or used in accordance with Article 89(2)55 of Regulation (EU) No 528/2012. [Am. 49]

Removed2a. 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.

RemovedBy… [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.

RemovedWhere 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.

RemovedWhen 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. [Am. 50]

Removed2b. 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.

RemovedBy… [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. [Am. 51]

RemovedArticle 5 Detergents containing micro-organisms

RemovedDetergents containing micro-organisms shall comply with the requirements laid down in Annex II.

RemovedArticle 6 Limitations on the content of phosphates and other phosphorus compounds

RemovedDetergents listed in Annex III shall comply with the limitations on the content of phosphates and other phosphorus compounds laid down in that Annex.

RemovedThe 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 2017/745. [Am. 52]

RemovedThe 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. [Am. 53]

RemovedArticle 6a Animal testing

Removed1. 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.

Removed2. Without prejudice to the general obligations pursuant to Article 1(1), the following shall be prohibited:

Removed(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;

Removed(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.

Removed3. 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].

Removed4. 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.

RemovedWhen 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 may, after consulting the relevant scientific Committee, Agency or body, adopt a decision authorising the derogation.

RemovedThat decision shall lay down the conditions associated with that derogation in terms of specific objectives, duration and reporting of the results. A derogation shall be granted only where:

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

Removed(b) the human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation. [Am. 54]

RemovedCHAPTER III OBLIGATIONS OF ECONOMIC OPERATORS

RemovedArticle 7 Obligations of manufacturers

Removed1. When placing detergents or surfactants on the market, manufacturers shall ensure that those detergents or surfactants have been designed and manufactured in accordance with this Regulation.

Removed2. Manufacturers shall draw up the technical documentation referred to in Annex IV and carry out the conformity assessment procedure referred to in that Annex.

RemovedWhere compliance of a detergent or surfactant with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall:

Removed(a) create a product passport in accordance with Article 18,

Removed(b) ensure that the data carrier is printed or otherwise placed on the label or on the packaging of the detergent or surfactant in a visible and legible manner in accordance with Article 18(3),

Removed(c) where relevant, affix the CE marking in accordance with Article 14, [Am. 55]

Removed(d) before placing detergents or surfactants on the market, manufacturers shall include a reference of the product passport in the registry referred to in Article 20(1).

Removed3. 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. [Am. 56]

Removed4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the test methods by reference to which conformity of a product is declared shall be adequately taken into account.

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

Removed5. Manufacturers placing on the market detergents or surfactants shall ensure that they comply with the labelling requirements laid down in Articles 15, 16 and 17.

Removed6. Manufacturers placing on the market detergents that do not meet the criteria for classification as hazardous within the meaning of Regulation (EC) No 1272/2008, shall provide to Member States’ appointed bodies referred to in Article 45 of that Regulation, the ingredient datasheet referred to in point 2.2 (e) of Annex IV.

RemovedManufacturers shall provide the ingredient data sheet to the Member States’ appointed bodies referred to in the first subparagraph in the following cases:

Removed(a) upon request from the Member States’ appointed bodiesat the time of placing a detergent on the market; [Am. 57]

Removed(b) when the detergent for which a data sheet has already been requestedprovided no longer corresponds to the information included in that datasheet. [Am. 58]

RemovedThe appointed body referred to in the first subparagraph and the medical personnel to which the information contained in the datasheet has been provided shall keep it confidential and use it for medical purposes only.

Removed7. 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 measuresactions 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 measuresactions taken. [Am. 59]

Removed7a. 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. [Am. 60]

Removed8. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic formformat 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. [Am. 61]

Removed8a. 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. [Am. 62]

RemovedArticle 8 Authorised representative

Removed1. 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. [Am. 63]

Removed2. Where the manufacturer is not established in the Union, the detergent or surfactant may only be placed on the Union market if the manufacturer designates, by a written mandate, an authorised representative.

Removed2a. 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. [Am. 64]

Removed3. 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. [Am. 65]

RemovedThe mandate shall allow the authorised representative to do at least the following:

Removed(a) verify that the product passport has been created in accordance with Article 7(2), point (a), that the technical documentation has been drawn up and the conformity assessment procedure has been carried out by the manufacturer in accordance with Article 7(2);

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

Removed(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; [Am. 66]

Removed(d) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by a detergent or surfactant covered by the authorised representative’s mandate.