Annex IV — CONFORMITY ASSESSMENT PROCEDURES

Part I Module A: Internal production control 1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Part, and ensures and declares, on the manufacturer’s sole responsibility, that the toy satisfies the requirements of this Regulation. 2. Technical documentation The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, to the extent relevant for the assessment, the design, manufacture and operation of the toy. The technical documentation shall contain at least the elements set out in Annex V. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Regulation. 4. CE marking and digital product passport 4.1. The manufacturer shall affix the CE marking to each individual toy that satisfies the applicable requirements of this Regulation. 4.2. The manufacturer shall create the digital product passport for a toy model and ensure that together with the technical documentation, it remains available for 10 years after the product has been placed on the market. The digital product passport shall identify the toy for which it has been created. 5. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by the manufacturer’s authorised representative, on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate. Part II Module B: EU-type examination 1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a toy and verifies and attests that the technical design of the toy meets the requirements of this Regulation. 2. EU-type examination may be carried out in any of the following manners: (a) examination of a specimen, representative of the production envisaged, of the complete toy (production type), (b) assessment of the adequacy of the technical design of the toy through an examination of the technical documentation and supporting evidence referred to in point 3, plus an examination of specimens, representative of the production envisaged, of one or more critical parts of the toy (combination of production type and design type), (c) assessment of the adequacy of the technical design of the toy through an examination of the technical documentation and supporting evidence referred to in point 3, without an examination of a specimen (design type). 3. The manufacturer shall lodge an application for EU-type examination with a single notified body of the manufacturer’s choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, as well as the name and address of that representative, (b) a written declaration that the same application has not been lodged with any other notified body, (c) the technical documentation, which is to make it possible to assess the product's conformity with the applicable requirements of this Regulation and is to include an adequate analysis and assessment of the risks, including the safety assessment referred to in Article 25; it is to specify the applicable requirements and cover, to the extent relevant for the assessment, the design, manufacture and operation of the toy; and it is to contain at least the elements set out in Annex V, (d) the specimens representative of the production envisaged; the notified body may request further specimens if needed for carrying out the test programme, (e) the supporting evidence for the adequacy of the technical design solution; it is to mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full; and it is to include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer’s behalf and under the manufacturer’s responsibility. 4. The notified body shall: For the toy: 4.1. examine the technical documentation and supporting evidence to assess the adequacy of its technical design; For the specimen: 4.2. verify that the specimen has been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or common specifications, as well as the elements which have been designed without applying the relevant provisions of those standards and/or common specifications; 4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or common specifications, these have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or common specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential safety requirements of this Regulation; 4.5. agree with the manufacturer on a location where the examinations and tests will be carried out. 5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 as well as their results. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. 6. Where the type meets the requirements of this Regulation, the notified body shall issue an EU-type examination certificate to the manufacturer. The EU-type examination certificate shall include a reference to this Regulation, a colour image, a clear description of the toy, including its dimensions, and a list of the tests performed, together with a reference of the relevant test report. The certificate shall contain the name and address of the manufacturer, an indication of the place of manufacture, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have annexes attached. The certificate and the annexes thereto shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control. Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type might no longer comply with this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the toy with the essential safety requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate. 8. Each notified body shall inform its notifying authorities of the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued. Member States, the Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, Member States and the Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate. 9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the toy has been placed on the market. 10. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. Part III Module C: Conformity to type based on internal production control 1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3 of this Part, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of the this Regulation that apply to them. 3. CE marking and digital product passport 3.1. The manufacturer shall affix the CE marking to each individual product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation. 3.2. The manufacturer shall create a digital product passport for a toy model and ensure that it remains available for 10 years after the toy has been placed on the market. The digital product passport shall identify the toy for which it has been created. 4. Authorised representative The manufacturer’s obligations set out in point 3 may be fulfilled by the manufacturer’s authorised representative, on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate.