What changed between the plenary report and the adopted text

Added:3. The economic operator shall ensure that appropriate corrective action is taken in respect of all the concerned toys that the economic operator has made available on the market throughout the Union.

Added:4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authorities shall take appropriate provisional measures to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it.

Added:The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

Added:5. The information referred to in paragraph 4, second subparagraph, shall include all available details, in particular the data necessary for the identification of the non-compliant toy including the unique product identifier, the origin of that toy, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:

Added:(a) failure of the toy to meet the essential safety requirements;

Added:(b) shortcomings in the harmonised standards referred to in Article 13;

Added:(c) shortcomings in the common specifications referred to in Article 14.

Added:6. Market surveillance authorities of Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned, and, in the event of disagreement with the notified national measure, of their objections.

Added:7. Where, within 3 months of receipt of the information referred to in paragraph 4, second subparagraph, no objection has been raised by either a market surveillance authority of a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed to be justified.

Added:8. Market surveillance authorities of other Member States shall ensure that appropriate restrictive measures, such as withdrawal of the toy from their market, are taken without delay in respect of the toy concerned, and shall inform the Commission and the other Member States of those measures.

Added:9. The information referred to in paragraphs 2, 4, 6 and 8 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020 and strictly enforce Article 19 of that Regulation given the vulnerability of children to defective, unsafe or counterfeit products. [Am. 168]

Added:Article 42 Union safeguard procedure

Added:1. Where, on completion of the procedure set out in Article 41(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission has reasons to believe that a national measure could be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.

Added:On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.

Added:The Commission shall address its decision to all Member States and shall without delay communicate it to them and the relevant economic operator or operators.

Added:2. If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant toy is withdrawn or recalled from their market, and shall inform the Commission accordingly.

Added:If the national measure is considered unjustified, the Member State concerned shall withdraw it.

Added:3. Where the national measure is considered to be justified and the non-compliance of the toy is attributed to shortcomings in the harmonised standards referred to in Article 13 of this Regulation or the common specifications referred to in Article 14 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 or amend the common specifications as appropriate.

Added:Article 43 Formal non-compliance

Added:1. Without prejudice to Article 41, where a market surveillance authority makes one of the following findings with regard to a toy, it shall require the relevant economic operator to put an end to the non-compliance concerned:

Added:(a) the CE marking has been affixed in violation of Article 15 or 16;

Added:(b) the CE marking has not been affixed;

Added:(c) the digital product passport has not been drawn up in accordance with Article 17; [Am. 169]

Added:(d) the data carrier through which the digital product passport is accessible has not been affixed in accordance with Article 17(5); [Am. 170]

Added:(e) the technical documentation referred to in Article 23 is either not available or not complete.

Added:2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority concerned shall take appropriate measures to restrict or prohibit the making available on the market of the toy, or ensure that the toy is recalled or withdrawn from the market.

Added:Article 44 National measures concerning toys which are compliant with the particular safety requirements but which present a risk

Added:1. Where, having carried out an evaluation under Article 41(1), a market surveillance authority finds that, although a toy made available on the market is in compliance with the particular safety requirements it poses a risk to the health and safety of persons, it shall require the relevant economic operator to take all appropriate measures, within a reasonable period of time prescribed by the market surveillance authority taking into account the nature of the risk to ensure that the toy, when made available on the market, no longer presents that risk, to withdraw the toy from the market or to recall it.

Added:2. The economic operator shall ensure that corrective action is taken in respect of all the toys concerned that the economic operator has made available on the market throughout the Union.

Added:3. The market surveillance authority of the Member State shall immediately inform the Commission and the other Member States of its findings and any subsequent actions taken by the economic operator. That information shall include all available details, in particular the data necessary for the identification of the toy concerned including the unique product identifier, the origin and the supply chain of the toy, the nature of the risk involved and the nature and duration of the national measures taken.

Added:4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not and, where necessary, propose appropriate measures.

Added:The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Added:5. The information referred to in paragraph 3 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020.

Added:Article 45 Commission action concerning toys that present a risk

Added:1. Where the Commission becomes aware of a toy or a specific category of toys made available on the market which presents a risk to the health and safety of persons but is nonetheless either in compliance with the particular safety requirements or raising doubts about such compliance, it is empowered to adopt implementing acts setting out measures to ensure that the toy or category of toys, when made available on the market, no longer presents that risk, to withdraw it from the market or to recall it where all of the following conditions are met:

Added:(a) it emerges from prior consultations with the market surveillance authorities that their approaches to dealing with the risk differ from one market surveillance authority to another;

Added:(b) the risk cannot, in view of its nature, be dealt with under other procedures laid down by this Regulation.

Added:2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(3). On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission is empowered to adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 50(4).

Added:CHAPTER VIII DELEGATED POWERS AND COMMITTEE PROCEDURE

Added:Article 46 Delegated powers

Added:1. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VI as regards the information to be provided in the digital product passport, in order to adapt it to technical and scientific progress and to the level of digital readiness of market surveillance authorities and of users and their supervisors. [Am. 171]

Added:2. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Article 19(1) by setting out that additional information among the information listed in Annex VI or that information on the non-compliance of the toy when measures are taken in accordance with Articles 41(2) or (4) and Article 44(1) is to be stored in the registry.

Added:When adopting the delegated acts in accordance with the first subparagraph, the Commission shall take into account the following criteria:

Added:(a) coherence with other relevant Union acts, where relevant;

Added:(b) the need to allow for the verification of the authenticity of the digital product passport; [Am. 172]

Added:(c) the relevance of the information for improving the efficiency and effectiveness of market surveillance checks and customs controls for toys;

Added:(d) the need to avoid disproportionate administrative burden for economic operators.

Added:3. The Commission is empowered to adopt delegated acts in accordance with Article 47 to supplement this Regulation by determining which of the information stored in the registry is to be controlled by customs authorities, in addition to the information set out in Article 20(3).

Added:4. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VII to this Regulation in order to adapt the list of commodity codes and product descriptions to be used for the purposes of Article 20(8). Those adaptations shall be based on the list set out in Annex I to Regulation (EEC) No 2658/87.

Added:5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex III in order to adapt it to technical and scientific progress.

Added:6. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in order to permit for a specified period of time a certain use in toys of a specific substance or mixture that is prohibited under Part III, point 4, of Annex II, or to limit a certain use that has been permitted. While assessing the requests for exemption and its duration, the Commission shall take into account the availability of alternatives and any potential adverse impacts on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant. Six months after the entry into force of this Regulation, the Commission shall adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in regard to nickel, in order to set out the validity period for the exemption from the generic prohibition under Part III, point 4, of Annex II, for that substance. The Commission shall justify any exemption granted and make this publicly available in an easily accessible and user-friendly manner. [Am. 251]

Added:7. The use in toys of a substance or mixture prohibited under Part III, point 4, points (a), (b), (db), (dc), (dd) and (de) of Annex II may onlyshall not be permitted whenunless all of the following conditions are met: [Am. 174]

Added:(a) it has been found to be safe by the European Chemicals Agency (ECHA), in particular in view due to the absence of the possibility of exposure, including the overall exposure from other sources, and under reasonably foreseeable conditions of use in accordance with Article 5(2), first subparagraph, taking particular account of the vulnerability of children; [Am. 175]

Added:(aa) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible; [Am. 176]

Added:(b) there are no suitable alternative substances or mixtures available, as established by ECHA based on an analysis of alternatives;

Added:(c) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.

Added:7a. The use in toys of a substance or mixture prohibited under Part III, point 4, points (c), (d) and (da) of Annex II shall not be permitted unless all of the following conditions are met:

Added:(a) it has been found to be safe by the ECHA, in particular in view of exposure, including the overall exposure from all potential sources as well as any known additional hazards from combined exposure to the different substances and mixtures present in the toy, and taking into account, in particular, the vulnerability of children;

Added:(b) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible;

Added:(c) there are no suitable alternative substances or mixtures available, as established by the ECHA based on an analysis of alternatives;