What changed between the plenary report and the adopted text

Added:Article 22 Conformity assessment procedures

Added:1. Manufacturers shall use the conformity assessment procedures referred to in paragraphs 2 and 3.

Added:2. If the manufacturer has applied harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all relevant safety requirements for the toy, the manufacturer shall use the internal production control procedure set out in Part I of Annex IV.

Added:3. In the following cases, the manufacturer shall use the EU-type examination procedure set out in Part II of Annex IV together with the conformity to type procedure set out in Part III of that Annex:

Added:(a) where harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all relevant safety requirements for the toy, do not exist;

Added:(b) where harmonised standards or common specifications referred to in point (a) exist but the manufacturer has not applied them or has applied them only in part;

Added:(c) where one or more of the harmonised standards referred to in point (a) has been published with a restriction, in the event that the restriction is relevant to the toy in question; [Am. 159]

Added:(d) where the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third party verification.

Added:4. The EU-type examination certificate issued in accordance with Part II, point 6, of Annex IV shall be reviewed whenever necessary, in particular in case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.

Added:Article 23 Technical documentation

Added:1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the toy complies with the essential safety requirements. It shall, in particular, contain the documents listed in Annex V.

Added:2. The technical documentation shall be drawn up in one of the official languages of the Union.

Added:3. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the language of that Member State.

Added:When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may fix a deadline for receipt of such file or translation, which shall be 30 days, unless a shorter deadline is justified in the case of serious and immediate risk to health and safety.

Added:4. If the manufacturer does not comply with the requirements set out in paragraphs 1, 2 and 3, the market surveillance authority may require the manufacturer to have a test performed by a notified body at its own expense within a specified period in order to verify compliance with the essential safety requirements.

Added:CHAPTER VI NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Added:Article 24 Notification

Added:Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.

Added:Article 25 Notifying authorities

Added:1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies for the purposes of this Regulation, and for the monitoring of notified bodies, including compliance with Article 30.

Added:2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

Added:3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26. In addition, that body shall have arrangements to cover liabilities arising out of its activities.

Added:4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Added:Article 26 Requirements relating to notifying authorities

Added:1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

Added:2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of their activities.

Added:3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

Added:4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, nor shall they offer or provide consultancy services on a commercial or competitive basis, however the notifying authority shall provide information to the economic operators about the procedures for the assessment and the conformity assessment bodies if requested to do so. [Am. 160]

Added:5. A notifying authority shall safeguard the confidentiality of the information they obtain.

Added:6. A notifying authority shall have a sufficient number of competent personnel and adequate resources at their disposal for the properefficient performance of their tasks. [Am. 161]

Added:7. A notifying authority shall monitor the nature and amount of tasks performed by subsidiaries of or subcontractors to notified bodies in accordance with Article 30.

Added:Article 27 Information obligation of notifying authorities

Added:Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

Added:The Commission shall make that information publicly available.

Added:Article 28 Requirements relating to notified bodies

Added:1. For the purposes of notification under this Regulation, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. It shall be accredited in accordance with Regulation (EC) No 765/2008.

Added:2. Conformity assessment bodies shall be established under the national law of a Member State and shall have legal personality.

Added:3. A conformity assessment body shall be a third-party body independent of the organisation or the toy it assesses.

Added:A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of toys which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered a third-party body for the purposes of the first subparagraph.

Added:4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the toys which they assess, nor the authorised representative of any of those parties. This shall not preclude use of the assessed toys that is necessary for the operations of the conformity assessment body or the use of those toys for personal purposes.

Added:A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of those toys, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Added:Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

Added:5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

Added:6. A conformity assessment body shall be capable of carrying out the conformity assessment tasks assigned to it by Annex IV and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

Added:At all times and for each conformity assessment procedure and each kind or category of toy in relation to which it has been notified, a conformity assessment body shall have at its disposal, or in place, the following:

Added:(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

Added:(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and ability of reproduction of those procedures;

Added:(c) appropriate policies and procedures that distinguish between tasks it carries out as a notified body and other activities;

Added:(d) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process.

Added:A conformity assessment body shall have the meansresources necessary to efficiently perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. [Am. 162]

Added:7. The personnel responsible for carrying out the conformity assessment activities (the ‘assessment personnel’) shall have the following:

Added:(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

Added:(b) satisfactoryin-depth knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; [Am. 163]

Added:(c) appropriatein-depth knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 13 of this Regulation and the common specifications referred to in Article 14 of this Regulation; [Am. 164]

Added:(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

Added:8. The impartiality of conformity assessment bodies, their top level management and assessment personnel shall be ensured.

Added:The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

Added:9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with its national law, or the Member State itself is directly responsible for the conformity assessment.

Added:10. The personnel of a conformity assessment body shall observerespect professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Intellectual property rights and trade secrets, in accordance with Directive (EU) 2016/943, shall be protected. [Am. 165]

Added:11. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 40, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.