What changed between the plenary report and the adopted text

Added:That 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:

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

Added:(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]

Added:CHAPTER III OBLIGATIONS OF ECONOMIC OPERATORS

Added:Article 7 Obligations of manufacturers

Added:1. 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.

Added:2. Manufacturers shall draw up the technical documentation referred to in Annex IV and carry out the conformity assessment procedure referred to in that Annex.

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

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

Added:(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),

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

Added:(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).

Added: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. [Am. 56]

Added:4. 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.

Added:When 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.

Added:5. 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.

Added:6. 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.

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

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

Added:(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]

Added:The 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.

Added: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 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]

Added: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. [Am. 60]

Added:8. 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]

Added: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. [Am. 62]

Added:Article 8 Authorised representative

Added: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. [Am. 63]

Added:2. 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.

Added: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. [Am. 64]

Added:3. 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]

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

Added:(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);

Added:(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;

Added:(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]

Added:(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.

Added:(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; [Am. 67]

Added:(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. [Am. 68]

Added: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. [Am. 69]

Added:4. The obligations laid down in Article 7(1) and the obligation to draw up technical documentation referred to in Article 7(2) shall not form part of the authorised representative’s mandate.

Added:Article 9 Obligations of importers

Added:1. Importers shall place only compliant detergents or surfactants on the market.

Added:2. Before placing a detergent or surfactant on the market importers shall ensure the following:

Added:(a) the manufacturer has carried out the conformity assessment procedure and drawn up the technical documentation referred to in Article 7(2);

Added:(b) the detergent bears the CE marking referred to in Article 14; [Am. 70]

Added:(c) the manufacturer has created the product passport referred to in Article 7(2);

Added:(d) the relevant information on the product passport has been included in the registry referred to in Article 20(1);

Added:3. Where an importer considers or has reason to believe that a detergent or surfactant is not in conformity with this Regulation, the importer shall not place the detergent or surfactant on the market until it has been brought into conformity. Furthermore, where the detergent or surfactant presents a risk to health or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

Added:4. Importers shall indicate their name, registered trade name or registered trade mark and, 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. [Am. 71]

Added:5. Importers shall ensure that detergents and surfactants that they place on the market comply with the labelling requirements laid down in Articles 15, 16 and 17.

Added:6. Importers shall ensure that, while a detergent or surfactant is under their responsibility, its storage or transport conditions do not jeopardise its compliance with this Regulation.

Added:7. When deemed appropriate with regard to the performance of a detergent or surfactant or the risks presented by them, importers shall carry out sample testing of such detergents and surfactants, investigate, and, if necessary, keep a register of complaints, of non-conforming detergents and surfactants and recalls of such detergents and surfactants, and shall keep distributors informed of any such monitoring.

Added: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 measuresactions 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 measuresaction taken. [Am. 72]

Added: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. [Am. 73]

Added:9. Importers shall keep the reference to the unique product identifier at the disposal of the market surveillance authorities for a period of 10 years after the detergent or surfactant has been placed on the market and shall ensure that the technical documentation can be made available to those authorities, upon request.

Added:10. Importers 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. 74]

Added: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. [Am. 75]

Added:Article 10 Obligations of distributors

Added:1. When making a detergent or surfactant available on the market distributors shall act with due care in relation to the requirements of this Regulation.

Added:2. Before making a detergent or surfactant available on the market distributors shall verify that the following conditions have been met:

Added:(a) the detergent or surfactant is accompanied by the required documents and by a label that meets the requirements laid down in Articles 15, 16 and 17;